Regulatory Affairs Specialist remote jobs

NewAmsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk for heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the world's preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity. NewAmsterdam Pharma (NAP) is seeking a Director, CMC Regulatory, to manage CMC Regulatory oversight and drive CMC sections of regulatory submissions during all phases of Clinical and Commercial products. Primary responsibilities will be to ensure regulatory submissions (such as IND, IMPD, NDA, and MAAs) are accurate, supported by source records, and meet expected execution timelines. This position is expected to be a driver of CMC regulatory project. This is a remote position with team building and conference travel expected, and will report to the SVP, Quality and CMC Regulatory Affairs. Key Responsibilities: Develop and implement regulatory strategies for drug development programs, ensuring alignment with business objectives. Lead the preparation, submission, and maintenance of CMC related regulatory filings and sections (examples but not limited to IND, IMPD, CTA, MAA, NDA). This includes project management of tasks and deliverables. CMC submission content plan (Module 2.3, 3, and CMC specific Module 1 documents) for marketing applications. Compile and review regulatory documents, ensuring scientific integrity and compliance. Understand, communicate, and provide Global strategic solution approach to managing regional differences Responsible for submission ready documents for publishing Key partner to interact with the CRO regulatory vendor to ensure deliverables are properly planned and CMC content is delivered in a timely manner Provide strategic regulatory guidance to internal stakeholders and subject matter experts on drug development, CMC, and labelling requirements. Facilitate meetings with SMEs for document review and comment resolution to regulatory submission documents. Lead the development and implementation of a change control system that meets the requirements to assess, track, and and file regulatory changes to support life cycle management of NAP's products. Responsible for CMC related communication and interactions with the FDA and other health authorities. Identify key risks relating to CMC strategy and offer solutions/guidance to SMEs for regulatory agency meetings, in all applicable regions from pre-submission for through commercialization for products at all stages of development, ensuring optimal communication and negotiation. Collaborate with clinical, CMC, and quality teams to proactively identify and address regulatory challenges and expedite drug development timelines. Stay up to date with evolving regulatory requirements and ensure company practices remain compliant with FDA, EMA, and ICH guidelines. Responsible for reviewing and documenting issues/events, assessing product quality and program regulatory impact. Partner with internal and external stakeholders to drive issue resolution, change control, deviation/CAPA identification and ensure timely closure. Provide CMC related content for safety reports and annual reports. Provide leadership and mentorship to team members. QMS Responsibilities Develop, review and approve GxP regulatory related controlled documents, such as: Policies, Standard Operating Procedures (SOPs), Work Instructions, and supporting documents related to GxP activities. Perform applicable Trainings such as inspection readiness. Assist with preparation of Health Authority inspections and necessary responses, as applicable. Work closely with Quality and CMC on recall preparation and if needed perform Recall and Field Alert activities. Requirements: Bachelor's degree in a scientific discipline, Chemistry and advanced degree preferred 15+ years in the pharmaceutical industry, with a minimum of 8 years in Regulatory. Quality Manufacturing background is a plus but not required. Proven track record of leading regulatory submissions including INDs, IMPDs, NDAs, and MAAs. Rest of World regulatory experience including Japan and China is preferred. Deep knowledge of FDA regulations, ICH guidelines, and global regulatory pathways for drug development as well as change control and reporting post approved product. Solid understanding of GxP standards, policies, and procedures (domestic and international) Experience and understanding of small molecule drug substance and non-sterile solid oral dosage drug product. Experience with managing vendors. Excellent verbal and written communication skills Collaborative problem-solver, with a proven track record to analyze complex issues to develop relevant and realistic plans, programs, and recommendations Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision Ability to travel domestically and internationally, approx. 10% of the time Remote position, US Eastern work hours expected. Salary and Benefits: We offer a competitive base salary, commensurate with experience. In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards. NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.

Washington, DC Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR CT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFR CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a VC-backed company that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide. The Director of Government Affairs will play a critical role in advancing Heartflow's business objectives by developing and executing strategies to engage government stakeholders, shape public policy, and secure fair and adequate reimbursement for Heartflow's current and future products and services. This position is responsible for building and nurturing relationships with key policymakers, including legislative and executive branches, and ensuring that Heartflow's interests are effectively represented at the federal level. The Director will manage the company's lobbying efforts, track legislative and regulatory developments, and ensure compliance with all relevant lobbying laws and regulations. This role requires a strategic leader with a deep understanding of the healthcare policy landscape, particularly in the medtech, diagnostics, and digital health sectors. This role is home-based in Washington, D.C., or within driving distance. Key Responsibilities: Stakeholder Engagement & Relationship Management Build and maintain strong relationships with key legislative and executive branch stakeholders to understand and advocate for Heartflow's business and policy priorities. Engage with policymakers, regulatory bodies, and other government stakeholders to promote Heartflow's interests, focusing on securing favorable policy and reimbursement outcomes. Work with Heartflow lobbying team to access political influences into HHS/CMS. Develop and manage comprehensive strategies to advocate for Heartflow's product reimbursement, working closely with the lobbying, legal, and regulatory teams to engage with CMS (Centers for Medicare & Medicaid Services) and HHS (Department of Health and Human Services). Collaborate with internal teams to create advocacy materials such as one-pagers, slide decks, and economic analyses that effectively communicate Heartflow's clinical and economic value to key stakeholders. Develop and maintain an in-depth understanding of clinical and economic data to tailor messaging to diverse government stakeholders. Legislative & Regulatory Monitoring: Monitor proposed legislation and regulatory changes, assessing their potential impact on Heartflow, its products, customers, and patients. Provide strategic insights and recommendations to senior leadership on emerging policy risks and opportunities. Advocacy Strategy and Execution Develop and implement comprehensive government relations strategies that align with the organization's objectives. Manage Heartflow meetings and execution with lobbying and DC team including preparing agenda, managing follow up tasks to completion, recording minutes, etc. Research and propose rate setting methodologies that could be utilized for Heartflow's products and keep abreast of CMS policies and trends to maintain or improve Heartflow product reimbursement. Coordinate with commercial team and Heartflow customers to advocate for reimbursement through public comment periods and via Congressional members for Heartflow reimbursement. Compliance: Ensure the organization's compliance with all relevant lobbying laws and regulations, including managing political contribution strategies. Educational Requirements & Work Experience: Education: Bachelor's degree in health policy, public health, business, or a related field required; advanced degree (MPH, MPP, MBA, or JD) preferred. 8+ years in health policy, market access, reimbursement, or government affairs within medtech, diagnostics, or digital health. Experience in the federal government a plus. Skills: Strong understanding of US government functions, policies, and legislation including an understanding of US coding, coverage, and payment system and the organizations of HHS/CMS and Congress. Strong analytical and interpersonal skills with the ability to interpret legislation and policy. Strong interpersonal skills to develop relationships with stakeholders. Self-starter with strong organization skills to track and manage interactions with many different stakeholders. Established relationships with government officials and regulatory bodies are a plus. A reasonable estimate of the yearly base compensation range is $180,000-$240,000, cash bonus, and stock options. Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination. #J-18808-Ljbffr

Join Our Trailblazing Team at Tiny House, Where Data Meets Creativity in Digital Advertising Are you passionate about blending the art of digital marketing with the science of data analytics? At Tiny House, we offer an unparalleled opportunity to harness your marketing talents and analytical prowess to drive meaningful impact for nationally recognized brands. Dive into a role where your expertise is valued, your creativity is encouraged, and your growth is inevitable. Be part of a dynamic team that thrives on collaboration, innovation, and delivering exceptional results. This is where your work not only contributes to our clients' success but also helps sculpt the digital advertising landscape. Who We Are: The Essence of Tiny House At the heart of the bustling Richmond startup community, Tiny House stands as a beacon for innovative digital marketing solutions. Our mission is to usher our clients into the world of modern performance advertising, where ads should be personalized, organic social and paid media intertwine, and the 3 As of automation, algorithms, and AI are things to be leveraged, not feared. With our proprietary Blueprint platform, we harness data to meticulously diagnose opportunities to deeply understand, locate, and engage with audiences across the digital sphere. Our unique account-specific newsletters, the "Tiny House Digests," exemplify our commitment to clarity, effectiveness, and fun in marketing, delivering bespoke insights and strategies that propel our clients forward. Join us, and contribute to a culture where creativity, efficiency, and a purpose-driven ethos flourish. Your Role and Impact As a Digital Advertising Analyst at Tiny House, you will: Strategically Manage and Optimize Campaigns across multiple digital platforms (Google Ads, Meta Ads, Pinterest Ads, LinkedIn Ads, connected TV, and more), tailoring each to the client's unique goals and audiences. Deep Dive into Data Analysis, leveraging real-time data to enhance campaign performance, identify trends, and inform strategic decisions. Your analytical skills will be crucial in optimizing results and ensuring client satisfaction. Develop Comprehensive Reports that not only track campaign performance but also provide insightful, data-driven recommendations for future strategies. Craft Tailored Digital Strategies and continuously refine KPIs to exceed client expectations and achieve outstanding results. Foster Collaboration and Communication, serving as a pivotal link between clients, internal teams, and partners to ensure cohesive marketing efforts. Create Engaging Stories through the "Tiny House Digest" and in client calls. Make complex data understandable and engaging for clients. Stay Ahead of Industry Trends, constantly seeking innovative opportunities for client growth and digital advertising excellence. Who You Are: Our Ideal Candidate Experienced in Digital Advertising, with 1-3 years of hands-on experience managing and optimizing digital advertising campaigns. A comprehensive understanding of digital marketing concepts, strategies, and industry-specific best practices. Agency background strongly preferred. Experience managing budgets of at least $25K per month. A Data Maven, with advanced proficiency in digital advertising platforms and a keen analytical eye for dissecting complex data sets using tools like Excel or Google Sheets. Highly Skilled in Communication, able to articulate strategies and insights clearly through verbal and written mediums, fostering strong relationships with clients and internal teams. An Organizational Powerhouse, adept at juggling multiple client projects with impeccable precision and efficiency. Why Tiny House? The Benefits Competitive Salary and Comprehensive Health Benefits with significant employer contributions. Flexible, Hybrid Work Schedule to balance in-office collaboration and remote work freedom. Generous PTO and Holiday Policy, ensuring work-life harmony. Vibrant Team Culture, with regular events, volunteer outings, and a buzzing startup work environment. Continuous Professional Development and Networking opportunities within the Richmond startup ecosystem. Fringe Benefits, including full parking reimbursement, team-curated snacks, Apple computer and AirPods, and the modern amenities of a sleek office space at the 1717 Innovation Center in downtown Richmond. Community Engagement, with a portion of profits supporting local initiatives that help those experiencing homelessness. If you're ready to leverage your analytical skills and advertising prowess in a role that truly matters, apply to join Tiny House today. Together, we'll distill the modern digital advertising world into actionable strategies that drive success, foster community, and make a real impact.

Job Title: Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave Job Contract Type: Full-time Job Seniority Level: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional All Job Posting Locations: Baltimore, Maryland, United States, Chicago, Illinois, United States, Irvine, California, United States of America, Philadelphia, Pennsylvania, United States, Portland, Oregon, United States, Raleigh, North Carolina, United States, San Diego, California, United States of America, San Francisco, California, United States of America, San Jose, California, United States of America, Santa Clara, California, United States of America, Seattle, Washington, United States of America, South San Francisco, California, United States of America, US360 MN New Brighton - 600 County Road D W Job Description Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist (Ad/Promo) - Shockwave Medical to join our team located in New Brighton, MN or Remote US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Senior Regulatory Affairs Specialist overseeing advertising and promotional Regulatory responsibilities, works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that advertising and promotion activities meet geography specific regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist, (Advertising/Promotion) is responsible for reviewing, editing and supporting compliance of SWMI advertising and promotional material and internal procedures/training. This individual supports decision-making for advertising and promotion regulatory activities. Essential Job Functions Collaboratively interface with marketing/sales personnel and other cross-functional departments and external entities, as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with SWMI commercial approvals and within established timelines. Maintain geography specific advertising and promotion regulatory policies, processes and SOPs and train key internal stakeholders. In collaboration with marketing personnel, assist RA leadership in establishing and maintaining product claims matrices for worldwide reference. Conduct Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives. Approve advertising and promotional materials to ensure compliance. Ensure that changes in product labeling are appropriately reflected in current promotions and advertising. Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use. Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and develop/implement corrective action plans for resolution of problematic issues with guidance from RA leadership. Identify and communicate emerging issues to RA leadership. Plan and conduct meetings, create project plans and timelines, and manage projects with guidance from RA leadership, when assigned. Exercise good and ethical judgment within policy and regulations. Other duties as assigned. Qualifications Minimum 5 years' experience in a regulated healthcare industry with Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred. Minimum 1-2 years of experience completing regulatory affairs reviews of advertising and promotional related material in a medical device environment. Pharmaceutical experience may be considered. Advanced knowledge of FDA guidelines and regulations with an emphasis on product promotional activities. Worldwide knowledge of advertising and promotional guidelines and regulations is a plus. Develop and/or maintain advertising/promotion documents such as a core claims document and related SOPs. Ability to work accurately and collaboratively in a fast-paced environment while managing multiple priorities. Apply effective communication skills, with the ability to convey messages in a logical and concise manner. Ability to consistently reinforce regulatory expectations and requirements. Think analytically with good problem solving skills. Effectively negotiate internally and externally with regulatory agencies. Clear and effective verbal and written communication skills with diverse audiences and personnel. Support and comply with the company's Quality Management System policies and procedures. Ability to act with an inclusion mindset and model these behaviors for the organization. Knowledge of business functions and cross group dependencies/ relationships. Ability to follow scientific arguments and identify regulatory scientific data needs. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Must be able to travel as needed, approximately 1-2 times a year. Proficiency in MS Word, Excel and PowerPoint required. Additional Information The anticipated salary range for this position is: Outside of Bay Area: $89,000- $143,750 Bay Area, California: $103,000-$165,600 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************** The anticipated base pay range for this position is : "Rest of US: $89,000- $143,750 BA: $103,000-$165,600" Additional Description For Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. For more details and to find similar roles, please check out the below Lifelancer link. **********************/jobs/view/69724a84cbc139058dc761a9aeac4373

Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch ™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia. The company recently announced an oversubscribed $75 million Series C financing round led by ARCH Venture Partners, with participation from Gates Frontier, Bezos Expeditions and other top-tier investors. The funds will accelerate product development, facilitate commencement of a pivotal clinical trial, and advance Synchron towards a first-in-class BCI market approval for the treatment of paralysis. The Synchron Switch ™ brain computer interface is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. Synchron is a dynamic, multi-disciplinary and rapidly growing team. Join our mission of developing a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment. Help people with previously untreatable conditions regain connection to the world. Principal Regulatory Affairs Specialist The Principal Regulatory Affairs Specialist is responsible for supporting regulatory strategy development, worldwide product approval submission activities and for ensuring regulatory compliance. This person is responsible for implementing policies, procedures, and practices for Regulatory Affairs. Collaboration with R&D, Marketing, Clinical, Quality, Operations and other functions is required to execute regulatory strategies from product inception, launch and throughout the product lifecycle. Responsibilities Participate in Product Development teams as needed, providing input on regulatory strategies, timelines, and direction. Review and approve technical documentation. Write and compile clear and concise regulatory submissions including IDEs, QSubmissions, PMAs etc. Lead regulatory project management and independently seek out necessary resources to drive submissions to approval Create necessary SOPs, work instructions and other materials necessary to support regulatory compliance at all stages of the product life cycle Advise the internal team and lead efforts to ensure regulatory requirements are met for initial submissions, responses, supplements and post-market obligations Contribute knowledge, expertise and experience to the cross-functional team to allow for streamlined workflows, timely and relevant submissions, and thoughtful and creative approaches for the BCI space Contribute to company knowledge base by leading initiatives to educate and train the team on relevant regulatory and quality processes Ability to manage multiple projects and work in a fast-paced, changing environment Develop productive working relationships with regulatory advisors and consultants Minimum Qualifications 6 years of experience in U.S. and global Class II or III medical device regulatory affairs (active implantable device is a plus) Submissions experience in medical devices, SaMDs, AI/ML-enabled medical devices, deep learning-enabled devices, and digital health software. Have experience in developing complex submissions. Strong organization and attention to detail. Work independently and cross-functionally with minimal supervision. Skills and Knowledge Proven ability to prioritize, conduct, and manage time to meet project deadlines Working knowledge of ISO 13485, design controls, IEC 60601, ISO 14708 Understands interaction of quality, clinical and regulatory processes Strong technical writing skills Good negotiation and written/oral communication skills Has supported audits Work location: Preferred Hybrid in Brooklyn, NY; open to remote At Synchron, we value our culture and the way we work together to achieve our goals. You will be among a group of hard-working, fun, and caring people who support each other and are passionate about bringing life-changing technologies to people. Synchron provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, ethnicity, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Salary range: $125,000 - $140,000

Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a wide variety of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers. This position provides an opportunity to transition from other private, public, government or military experience to a 3M career. The Impact You'll Make in this Role As a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative people around the world. Here, you will make an impact by: Leading the regulatory compliance, Life Cycle Management, and sustainability requirements for existing and new hardgoods products in Automotive Aftermarket's Collision Repair business. Technical activities include interpreting regulations, performing assessments of safety to human health and the environment, addressing liability avoidance, and supporting sustainable business decisions. Collaborating with product development teams within the division, as well as corporate Subject Matter Experts, to identify potential hazards associated with the use of 3M products that incorporate electrical, electronic, mechanical, or other energy functions and are typically durable. Identify, plan and support execution of product compliance testing to meet applicable regulations for timely global product introductions and changes Determining regulatory pathway through a global regulatory assessment of product changes including developing and maintaining documentation relevant to the assessment of risk to human health and the environment. Your Skills and Expertise To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications: Bachelor's of Science degree or higher (completed and verified prior to start) in Biology, Chemistry, Engineering, Science or related discipline from an accredited institution Seven (7) years of product regulatory and/or compliance experience or mechanical or electrical design experience in a private, public, government or military environment Additional qualifications that could help you succeed even further in this role include: Master's degree or higher in Biology, Chemistry, Engineering, Science or related discipline from an accredited institution Five (5) years of hardgoods engineering or regulatory compliance experience in a private, public, government or military environment. Proficiency in OSHA, REACH and EPA requirements. Proficiency in regulations, standards and guidance impacting hardgoods compliance such as CE, EU RoHS, Machinery Directive, EMC Directive, Low Voltage Directive, Radio Equipment Directive, ATEX, UL. Strong interpersonal skills, written and verbal communication skills, able to build internal and external networks and communicate effectively Self-starter who can effectively work in a fast-paced environment, with an appropriate sense of urgency Experience working on and organizing multiple priorities Exceptional organization, as well as written and verbal communication skills Current, valid Driver's License. Work location: Hybrid Eligible (Job Duties allow for some remote work but require travel to 3M Center Maplewood, MN at least 2 days per week) Travel: May include up to 10% domestic/international Relocation Assistance: May be authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being 3M offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. Chat with Max For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting Applicable to US Applicants Only:The expected compensation range for this position is $137,439 - $167,981, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: ******************************************************************* Faith Posting Date Range 03/24/2025 To 04/23/2025 Or until filled All US-based 3M full time employees will need to sign an employee agreement as a condition of employment with 3M. This agreement lays out key terms on using 3M Confidential Information and Trade Secrets. It also has provisions discussing conflicts of interest and how inventions are assigned. Employees that are Job Grade 7 or equivalent and above may also have obligations to not compete against 3M or solicit its employees or customers, both during their employment, and for a period after they leave 3M.Learn more about 3M's creative solutions to the world's problems at ********** or on Instagram, Facebook, and LinkedIn @3M.Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Pay & Benefits Overview: https://**********/3M/en_US/careers-us/working-at-3m/benefits/3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, pregnancy, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. 3M Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application, you will be asked to confirm your agreement with the terms.

Job TitleSenior Regulatory Affair SpecialistJob Description Sr. Regulatory Affairs Specialist In this role you The Senior Regulatory Affairs Specialist plays a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant with global regulatory rules and standards. This position reports to the Head of Regulatory Affairs for IGTD-CV. Your role: Advise internal stakeholders (R&D, Marketing, Manufacturing, etc.) regarding laws, regulations, and guidance as they relate to the CV products portfolio to ensure regulatory inputs and outputs are in alignment with regulatory authority expectations and company objectives. Develop and implement global regulatory strategies, including submission risk mitigations, through deep understanding of the product's technical characteristics and regulatory landscape. Achieve successful device clearances/approvals for the US, Canada, EU and support licenses/registrations of devices worldwide through creative problem solving and high-quality submissions. Present to and communicate with internal stakeholders and regulatory agencies, as needed. Provide support as it relates to medical device submissions and certifications during product surveillance and QMS audits, as needed. This Hybrid-based role may require travel up to 10%. You're the right fit if: 5+ years Regulatory Affairs experience within regulated medical device/technology environments, including regulatory submissions (e.g., US FDA 510(k), PMA, IDE, Q-Subs, EU MDR Technical Document) in an area relevant to cardiovascular, imaging, sterile disposable, and/or hardware/software devices. Experience with Software Function (MDSW) and Artificial Intelligence/Machine Learning is a plus. Demonstrated a Sr-level of Regulatory Domain knowledge and expertise by leading others (e.g., product development core team) in global regulatory matters of diverse product categories. A bachelor's degree (master's degree desired), preferably in Regulatory Affairs and/or a science or engineering-related field. RAPS RAC credential is a plus. Strong written, oral, and interpersonal skills to effectively compose agency submissions and collaborate cross-functionally. Experience in the use of MS Office and Adobe Acrobat. Knowledge of PLM software, such as Windchill is a plus. Environmental job requirements with or without accommodation for this Office/Remote position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an office role About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our commitment to diversity and inclusion. Philips Transparency Details The pay range for this position in San Diego, CA is $82,000 - 150,000, Annually. The pay range for this position in Plymouth, MN is $82,000 - 140,000, Annually. The pay range for this position in Colorado Springs, CO is $82,000 - 140,000, Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA, Plymouth MN, Colorado Springs, CO. #LI-PHI This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

LMI is seeking a Senior Regulatory Affairs SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology. LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers' unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies. LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible! Responsibilities Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics. Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals. Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed. Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work. Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents. Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise. Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work. Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space. Provide recommendations for project development level portfolio management and oversight as required. Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts. Serve as the primary interface with BARDA, industry and FDA senior leadership on regulatory affairs matters. Supervise less experienced Regulatory Affairs Analysts. Provide subject matter expertise in regulatory affairs supporting Medical Countermeasures (MCM) development pathways against potential public health threats, to include natural occurring epidemic threats such as influenza as well as chemical, biological, radiological, and nuclear threats. These technologies/products cross the gamut of vaccines, drugs, and devices. Coordinate with program managers, scientists, and other subject matter experts as required. Strategize innovative regulatory approaches to MCM development against emerging threats. Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges. Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities. Serve as a Regulatory Affairs Subject Matter Expert for multiple programs and projects involving development and manufacturing of vaccines and other countermeasures for influenza and emerging infectious diseases. Provide scientific/technical/program management advice for assigned programs and projects and work with the Government/Contractor Project Team to implement Regulatory plans for assigned projects. Development of methodologies and procedures particular to CBER vaccine & biologics products Development and management of regulated studies. Oversee validation and operation of cGMP manufacturing facilities for vaccines and biologics. Assist in the compliance with contract requirements, federal regulations, and guidelines. Provide conceptual ideas and insights for preparedness and response to emerging infectious diseases. Prepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals. Support contract initiation/negotiation efforts. Participate in contract kick-off and ongoing meetings at supported company sites. Draft meeting minutes, trip reports, and technical assessments and recommendations on the Regulatory aspects of BARDA-contractor interactions. Review and comment on supported industry partner regulatory strategy, as assigned. Review supported industry partner submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Monitor supported industry partner project timelines for FDA submission. Participate or act as regulatory representative on various cross-functional teams, as assigned. Participate or lead regulatory interactions with FDA, as assigned. Maintain knowledge on the US competitive landscape, regulatory environment, regulations, and guidance. Attend and participate in industry conferences on BARDA's behalf. Provide Regulatory Research and Intelligence support for team as assigned. Qualifications Minimum of fifteen (15) years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry Application of master's degree or higher in biology, microbiology, chemistry, toxicology, or pharmacy with commensurate experience Experience in FDA engagement and development of regulatory documents Deliverables would include work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts Ability to obtain a public trust clearance. You must be a U.S. citizen.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds… ClinChoice, is searching for an experienced Senior Regulatory Affairs Specialist Consultant (OTC products) with REMOTE option in DENMARK for 12 months contract to work with one of our Consumer Health partners, with a focus on over-the-counter (OTC) Pharmaceuticals. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts. The Senior Regulatory Affairs Specialist has a thorough understanding of the regulatory environment in Denmark and other Nordic countries, including submission requirements, approval pathways, and compliance activities, with a focus on their impact on business objectives. They ensure the success of product registrations, line extensions, and new claims in alignment with the business plan. The specialist manages the coordination, compilation, and submission of applications for medicinal products, medical devices, food supplements, and similar products to regulatory agencies. They also maintain compliance with local regulations and quality system requirements for all products. Main focus is OTC medicinal products Main Job Tasks and Responsibilities: KEY RESPONSIBILITIES Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant. Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims. Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines. Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority. Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level. Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally Ensures that all products comply with local regulatory and quality system requirements. Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions. Reviews and approves promotional materials for assigned local products and assists in claim support. Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. Ensures that the enterprise Regulatory systems are accurate and fully maintained Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives. Supports internal and external audits and inspections in collaboration with quality function SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE Relevant Bachelor's Degree or higher 6+yrs related regulatory experience Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Medical Devices and Food Supplements. Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions through the product lifecycle Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance Full Proficiency in Danish and English The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Keywords: Regulatory Affairs, Reg Affairs, RA, Over the Counter, OTC, Consumer Health, medicinal products #LI-PR1 #LI-REMOTE #Associate #Contract

Employee Type: exempt full-time Division: Clinical Monitoring Research Program Facility: Telework: US Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. PROGRAM DESCRIPTION Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical and administrative support to the National Cancer Institute's Center for Cancer Research's (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA Provides administrative coordination and general logistical support for regulatory activities Monitors the review process and maintains detailed, complete, and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Provides data and documents collection and compilation for regulatory filing with the Food and Drug Administration (FDA) and other regulatory authorities Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent, and other clinical documents Collaborates with investigators to resolve any protocol/data issues Provides technical review and report preparation Streamlines the protocol development timeline Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Attends and prepares minutes for the Branch Protocol Review Committees Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols Converts protocols from word format to .pdf with bookmarks Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server This position is remote, with minimal travel to the office required. Office is located in Rockville, Maryland Out of area candidates will be considered BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field. (Additional qualifying experience may be substituted for the required education) Protocol Coordinator II - In addition to educational requirements, a minimum of two (2) years progressively responsible clinical trial regulatory documents development, submission and management experience Protocol Coordinator III - In addition to educational requirements, a minimum of five (5) years progressively responsible clinical trial regulatory documents development, submission and management experience Foreign degrees must be evaluated for U.S. equivalency Ability to serve as a liaison with various NCI staff and Principal Investigators to initiate and complete tasks relating to oncology clinical protocols Ability to interpret International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials Advance experience of formatting Word and Adobe documents Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Knowledge of clinical data report preparation Proficiency with Microsoft software applications Experience with progressively increasing responsibility in clinical trials protocol development and management processes. Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) #readytowork

We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits. At Aerin Medical our values show up as: always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation and being all in. As the Senior Regulatory Affairs Specialist, you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care. PURPOSE OF THE JOB: This position is responsible for maintaining Aerin quality system to meet applicable regulatory requirements and providing regulatory expertise to R&D, marketing and quality functions on regulatory standards and requirements. The job scope includes product registration, product labeling and promotional material review, change notification, regulatory reporting and compliance activities. MAJOR DUTIES AND RESPONSIBILITIES: Lead the preparation and submission of product registration application/dossier for new medical devices and modifications to existing devices. Ensure device complies to 21 CFR 820 and EU MDR requirements Lead and collaborate with cross-functional team members in preparation activities for responses to regulatory authority queries. Communicate directly with regulatory authorities such as FDA, Health Canada, the EU Authorized Representative, Competent Authorities and/or Notified Bodies. Identify need for regulatory or quality processes & standardization and work closely with RA/QA leadership to solve. Assess regulatory impact of product/process change. Submit and obtain regulatory change notification or approval. Support and manage key regulatory and quality initiatives as assigned Support other department projects (e.g. by R&D, Sales & Marketing, Clinical) and queries, ensuring applicable regulatory related requirements are met Monitor, maintain and track product registration licenses and validity status Create and maintain device technical documentation and Declarations of Conformity. Prepare and submit post-market vigilance, adverse event, product field corrective action, recall, advisory notice and related documents to regulatory authorities in a timely manner Review and approve product label and promotional materials for compliance with applicable regulations. Establish and maintain procedures to fulfill country-specific regulatory requirements Keep abreast of changes in regulatory environment. Provide advice to management on impact of change(s) to business of such regulatory changes, where applicable Prepare and conduct QMS related trainings, as applicable. Conduct gap analysis of new and revised standards/regulations Drive/support readiness of internal/external regulatory body audits/inspection Drive resolution and closure of audit findings and/or inspection findings, if any Keep abreast of changes in regulatory environment. Provide advice to management on impact of change(s) to business of such regulatory changes, where applicable Requirements EDUCATION REQUIREMENTS: Bachelor's degree or diploma preferably in a Scientific, Engineering or similar discipline EXPERIENCE REQUIREMENTS: At least 3 or more years of experience in regulatory affairs and/or quality management systems in medical device industry is required Good understanding of ISO 13485, EU MDD/MDR, FDA QSR 21 CFR Part 820, and ISO 14971 is required. Must have hands-on registration experience with FDA 510(k), and EU MDR product submissions. Experience with MDSAP is advantageous. Experience in promotional material review is beneficial. Prior working experience in a manufacturing and/or device design authority environment preferred. Experience with single-use sterile devices, biological safety, devices containing software, cybersecurity requirements is desired. OTHER QUALIFICATIONS: Self-motivator with strong sense of ownership on assigned responsibility Capable of driving results through others Proactive with resilient drive towards achieving department and organization's goals Resourceful and possess good problem-solving skills Demonstrated ability to work collaboratively with cross-functional departments and stakeholders in a constructive manner Ability to view issues from a broad and detailed perspective Excellent interpersonal and communication skills (both verbal and written) and capable of effective communication with all levels of organization BENEFITS AND PERKS: Our culture is rooted in our core values every day, in everything we do. Our benefits focus on the 5 dimensions of wellbeing: physical, financial, emotional, career and community. Physical benefits include Medical - PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. Financial benefits include HSA/FSA, 401k with company match, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). Career and Learning & Development opportunities with Aerin led leadership trainings. Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving. Salary Description 110k - 125k

We are looking for a Regulatory Analyst within our consulting team. This individual will work within our Regulatory Engagement Team helping clients to understand and assess critical regulations and programs central to decarbonization. Our clients depend on revenue streams from the sale of emissions reductions credits - the majority of which are RINs under the federal Renewable Fuel Standard (RFS), LCFS credits under California's Low Carbon Fuel Standard (LCFS), Oregon Clean Fuel Program (CFP), other voluntary carbon programs, and emerging regulations. Examples of new and emerging regulations/commitments include Washington's Clean Fuel Standard, Canada's Clean Fuel Regulations, the airline industry's CORSIA program, and various ESG reporting and data management needs. The successful candidate will have direct experience or knowledge of the Renewable Natural Gas industry. The Regulatory Analyst will have the following responsibilities: 1. Work within a team of Carbon Consultants to advise clients in the following areas of renewable and low carbon programs including: i. Federal Renewable Fuel Standard (RFS) ii. California Low Carbon Fuel Standard (LCFS) iii. Oregon Clean Fuels Program (CFP) iv. Washington Clean Fuel Standard (CFS) v. Canada Clean Fuel Regulations (CFR)

Job Details Remote - Remote1, OH Fully Remote Full Time Bachelor's Degree None Standard Business Hours OtherDescription Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists. Summary Under the direction of the Senior Manager Regulatory Affairs, the Senior Regulatory Affairs Specialist will draft and file documentation and submission materials in support of global product registrations, assuring compliance to regulations and guidelines and securing timely marketing authorizations according to agreed-upon plans. This position will manage communications with regulatory authorities, including submissions, product registrations, and execution of any post market commitments as required. Regulatory review of the product labeling, promotional material and e-labeling forms an integral part of this role. Reporting Relationships The Senior Regulatory Affairs Specialist will report to the Senior Manager Regulatory Affairs. Major Duties and Responsibilities Coordinate, compile and submit U.S, and/ or International regulatory submissions, including filing and/or creation of PMAs, IDEs, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations. Develop 510k/ PMA (US) submissions for class II and III in vitro diagnostic medical devices. Generate documents and/or oversee generation of documents (pre-clinical and clinical) to be submitted to the US FDA in order to secure approvals to market products in the USA. Develop pre-clinical (analytical) and clinical testing protocols for in vitro diagnostic medical devices as defined by US FDA Special Controls or applicable CLSI / internationally harmonized standards. Handle multiple submissions and respective timelines (PMA, 510ks). Apply advanced regulatory expertise to the evaluation and solution of submission problems and drive product change assessments and define regulatory impact of product changes in global markets. Conduct regulatory intelligence/research to assist in preparation of regulatory strategies and plans. Review and approve assigned product labeling, advertising, and promotional materials, to ensure full compliance with all applicable and relevant labeling guidelines. Participate in cross-functional product meetings and guide teams to provide content for US and/or international submissions. Communicate with and maintain productive, constructive relationships with regulatory bodies as required - US FDA, Health Canada, and other in-country regulatory agencies as needed. Consult closely with marketing and sales in support of registering products in the desired territories. Represent Regulatory Affairs in audits/internal audits and inspections as appropriate. Maintain ongoing surveillance and analysis of pertinent in vitro diagnostic medical device regulations to ensure submission requirements world-wide are current and up to date ensuring new or modified requirements are conveyed to the appropriate personnel. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Write, update, and manage regulatory SOPs. Mentor and train team members inside Regulatory Affairs and stakeholders outside core teams. Perform miscellaneous job-related duties as assigned. Uphold and adhere to the Tosoh America culture and guiding principles. Education Bachelor's degree in biology, chemistry, bioengineering or related scientific area Skills and Qualifications Minimum of 8 years of IVD Regulatory Affairs experience required. Working experience with 510(k) or PMA Submissions required. Proficient/knowledgeable in the aspects of regulatory strategy creation, design control, Quality Systems. Experience in direct and positive communication with regulatory agencies. Experience as RA representative on project core teams providing active and successful regulatory guidance and RA strategies. Experience in the balance and application of regulatory requirements. Strong oral and written communication skills, as well as the ability to provide scientific presentations. Ability to compile data and summarize results. Continuous improvement minded, familiar with balancing Quality and the need for efficiency. Regulatory Affairs Certification preferred (e.g., RAPS) Physical Requirements The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to travel by auto and air, including international. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Working Conditions This position might require visits to customer sites which are medical facilities. These facilities may have certain requirements which TOSOH representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings. Must agree to provide required immunization records or agree to acquire required immunizations to gain access to customer sites, as required by, customers. You may be required to register at vendor credentialing companies. Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans

Job Details ZO Skin Health HQ - Irvine, CA Full Time $100,000.00 - $115,000.00 Salary/year Description Summary: The purpose of the Sr. Regulatory Specialist position is to assess products, product changes and formulations for reportability to appropriate regulatory agencies. Primary responsibilities include supporting the department with the approval and review of claims evidence, labels, advertising, regulatory acceptability of ingredients, and critical analysis/strategic solutions to ensure regulatory compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success. As part of the Quality Assurance/ Regulatory Affairs team, they will utilize their knowledge of their respective agencies to bring the best solutions to ZO Skin Health's consumers. Essential Duties and Responsibilities: Performs regulatory assessments of formulations and labeling for various regions including but not limited to Canada, EU, ASEAN, Japan and for various product types including cosmetics and OTC drugs. Reviews chemical ingredients and determines the warning labels for each product. Reviews claims for marketing collateral and website content and determines acceptability. Assists in monitoring regulations and standards for changes and assesses impact. Communicates significant issues or developments identified during regulatory activities and provides recommended process improvements to management. Coordinates and compiles Regulatory documents that are intended to be submitted to FDA and other Regulatory Agencies as required including international registration documents for cosmetic and drug products. Evaluates proposed product formula modifications for global regulatory impact. Liaises with international distributors and partners plus internal departments to request, coordinate and provide regulatory information. Maintains documentation and related systems necessary for efficient operation of the department. Provides advice and support to junior staff. Other Duties and Responsibilities: Maintain a clean work environment May assist with vendor, customer and item set up. May perform other duties as needed in order to assist with ZO Skin Health operations. Work Environment: The work environment is indoors in a professional office environment. The floor surfaces are carpeted in office areas and conference rooms with vinyl floor covering typical in hallways, break rooms and computer rooms. Occasionally, they may work in a warehouse environment, as part of a project. Work Hours: The work schedule is 5 days per week, 8 hours per day. Initial start time may vary, with work hours typically from 8am-5pm. Work hours and shifts are subject to change depending on operating business conditions and needs. The position resides in Orange County but is hybrid with 2 days being remote work. Physical and Mental Demands: Sedentary, exerting up to 10 pounds of force occasionally, or negligible amounts of force frequently, to move objects. This job also requires constant sitting. Constant use of the upper extremities is required to reach, handle, and position tools and equipment. The employee must know and follow proper safety protocols and maintain a professional and polished appearance. They must be able to efficiently use Microsoft Office Programs and company information systems to retrieve information, generate documents, organize project plans/schedules and coordinate meetings. The employee must also be able to maintain and preserve confidentiality of company information, exhibit strong interpersonal skills and the ability to build relationships with internal stakeholders, including international affiliates. Supervisory Responsibilities: None Qualifications A Bachelor's degree in a related science discipline is required. Minimum seven (7) years working in a pharmaceutical, CPG, or health/cosmetics industry preferred. The employee must be proficient in Microsoft Office (Excel, Word, Outlook and Power Point). The employee must be highly proficient in written and verbal communication in English as well as have strong technical writing and editing skills. They also must possess excellent analytical skills to read, interpret and summarize scientific material, regulations, guidelines and medical information. The employee needs to possess thorough research skills and strong working knowledge of scientific guidelines and terminologies.

Job Purpose/ Summary: Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist, and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs. What You'll Do: Assist/Advise project teams on all regulatory requirements for clinical studies Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings Review and adapt study specific documents according each country and site requirements Perform / oversee IRB/EC/CA and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements Receive and process study documentation from sites, check content and quality as well as completeness Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy Preparation and/or quality check and filing of site adapted ICF according to local requirements Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements Compiling and/or assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist) Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs Prepare for Sponsor or Agency audits and inspections QC and QA of various study related Regulatory documents and reports Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope Attend internal and external study meetings and regulatory status reports for each site and country during study meetings Represent the Regulatory Department in capabilities and bid defense presentations Train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs Sites budgets and Sites contracts management, depending from Countries/Regions What You'll Bring: Associate's or Bachelor's degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience At least 5 years of relevant pharmaceutical, site, or CRO Regulatory experience About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit **************** Why CTI? Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department. Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program. Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market. Important Note In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from **************** email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (****************) or from our verified LinkedIn page. Please Note We will never communicate with you via Microsoft Teams or text message We will never ask for your bank account information at any point during the recruitment process

JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Responsible for determining the path to market for new and modifications to existing products in compliance with Regulations of intended market territory and for independently guiding teams on the required deliverables to support the Global Regulatory status of products distributed by AngioDynamics Inc. Essential Duties and Responsibilities * Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review. * Leads in the development and implementation of Regulatory strategies for new and modified medical devices. * Researches and prepares recommendations on pathway for a new device, proposed device change or modification, independently (e.g. 510(k), PMA, Technical Documentation, Shonin, Canadian License). * Apply scientific/technical knowledge to guide and strengthen development of regulatory submissions. * Compile necessary information and prepare Regulatory license applications that meet specific country requirements to support international markets, as well as internal regulatory file documentation. * Prepare and maintain Technical Documentation Files and IC Dossiers. * Review and approve device labeling and advertising materials for compliance with Regulatory product approvals (submissions/licenses) as well as applicable country regulations; analyze, recommend, and assure implementation of appropriate changes. * Maintain awareness of global regulatory requirements; review, create, develop, and implement global regulatory affairs procedures for marketed products to ensure company's regulatory compliance status. * Review and recommend action on product and manufacturing changes in compliance with applicable regulations. * Act as a core team member on development teams, providing Regulatory Affairs input and guidance throughout the product development cycle. * Develop and maintain product listing/establishment details required to prepare documentation for product importation into US and International sites. * Prepare Export Certificates (CFGs, CFS, etc.) - must have and apply knowledge of specific country requirements to lead in obtaining approvals from US regulatory agencies and International embassies. * Prepare product and establishment registration/listing with Regulators (e.g., US/FDA, Customs, Europe, Australia, Health Canada, Brazil, LATAM and APAC countries). * Collaborate with internal (Quality/Ops/R&D) and external (Partners/Distributors) groups to obtain documentation necessary to develop required Field Action reports to Regulators. * Primary contact with global Regulatory partners. * Lead regulatory projects as required. Effectively coordinate with cross-functional team members to achieve timely results. * Contribute and lead as a team member on projects sustaining the Regulatory and Quality compliance of products and the continued enhancement of the organization. * Support and maintain Quality initiatives in accordance with the Quality Policy. * Continuously assess and support implementation of ways to improve Quality. * This position has potential for travel to domestic and international facilities and meetings. * May perform other duties as assigned. Education and Experience * Bachelor's Level of Degree in the scientific or technical discipline field of study. * Eight years of demonstrated experience in Regulatory Affairs or equivalent knowledge. * Master's degree, Medical industry experience, and/or RAC Certification preferred. Skills/Knowledge * Experience in the following computer software applications: Microsoft Office, Adobe Acrobat, Agile PLM System. Must have data analysis skills. * In depth understanding of product development process and design control. * Effective research, analytical and sound decision-making skills. * Ability to work independently. * Expert knowledge of FDA, MDR and other international regulations. * Ability to manage contractors or other resources to complete and update compliant Post-market Clinical Follow-up studies and Clinical Evidence reports. * Ability to effectively manage several projects simultaneously and independently to timely completion. * Exceptional interpersonal skills. * Strong organizational skills. * Strong written and oral communication, technical writing and editing skills. * Project management skills. * Ability to effectively communicate both internally and externally. * Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.

More than a career - a chance to make a difference in people's lives. Build an exciting, rewarding career with us - help us make a difference for millions of people every day. Consider joining the Duke Energy team, where you'll find a friendly work environment, opportunities for growth and development, recognition for your work, and competitive pay and benefits. The location for this position is 299 1st Ave N in St Petersburg, FL. Job Summary The Senior Rates & Regulatory Analyst will serve as a member of the Duke Energy Florida Rates and Regulatory Strategy department. This person will be involved in development of regulatory filings, including setting retail and wholesale rates for Duke Energy Florida. Familiarity with electric utility regulatory and financial structures is highly desired. The Senior Rates & Regulatory Strategy Analyst would assist other team members in rate and regulatory analysis and execution. This position will be based in St Petersburg, FL. This position will report to a manager/director but will work in a matrixed environment for increased career growth and diversity. Responsibilities General responsibilities: Provide regulatory support for Duke Energy Florida. Assist in cost recovery processes related to retail clauses; prepare related worksheets, schedules, exhibits and testimony; support Duke Energy Florida witnesses in various ways such as responding to discovery and audit requests. Prepare regulatory filings, special studies, and analyses in support of regulatory filings and agreements. Assist in retail rate case activities and other regulatory initiatives to accomplish appropriate cost recovery for Duke Energy Florida, including research, data gathering, preparing related worksheets, schedules, and providing support for expert witnesses. Understand and comply with state and federal regulatory requirements related to electric rates. Collaborate with internal and external stakeholders to share subject matter expertise, provide necessary information, and respond to inquiries. Assist in the communication of regulatory and cost recovery concepts to both internal and external audiences. Prepare various rate reports and statistical reports with an effort towards continuous improvement Administrative tasks as assigned Basic/Required Qualifications Bachelor's degree in accounting, finance, business, mathematics or other related degree In addition to bachelor's degree, four (4) years minimum of work experience Desired Qualifications Background in regulatory, rates, finance, accounting or audit Ability to interpret, develop, and use data-driven, complex spreadsheets in Microsoft Excel Demonstrated effective analytical and problem-solving skills Attention to detail, including identification of irregularities in data and commitment to high level of accuracy Proficient in Microsoft Products: Excel, Word, and PowerPoint Strong written and verbal communication skills Ability to verbally explain calculations and filings to others Good time management and organization skills Ability to meet deadlines and work with minimal supervision Ability to seek guidance from teammates and effectively enlist the support of others in meeting deadlines Ability to coordinate work and deadlines between multiple departments ensuring timely completion of responsibilities. Ability to foster good relationships with teammates and others throughout the Company Ability to work within a matrixed environment Regulated industry work experience Exposure to or familiarity with the FERC Uniform System of Accounts Rate case support experience CPA or public accounting or internal auditing experience Strong interpersonal communication skills: ability to influence others, gain support of proposals and recommendations Strong analytical skills; ability to recognize trends and irregularities in complex calculations and explain variances by researching and identifying relevant, underlying causes of changes in results Willingness to assist the Rate department with new assignments Familiarity with Peoplesoft Financial System, exposure to PowerPlan Fixed Asset system, knowledge of other Duke financial systems and tools such as SAP Working Conditions M - F Office environment (with opportunity to work remotely as circumstances allow - up to 2 days a week) with extensive use of a computer. Office located in St Petersburg, FL Extended hours may be required to meet deadlines, especially in periods of rate cases, financial audits and clause filings. Local travel - 5%. Occasional travel to Tallahassee, FL Hybrid mobility classification - work will be performed from both remote and onsite locations after the onboarding period. However, hybrid employees should live within a reasonable commute to a listed Duke Energy facility. #LI-AB1#LI-Hybrid Travel Requirements 5-15%Relocation Assistance Provided (as applicable) NoRepresented/Union PositionNoVisa Sponsored PositionNo Posting Expiration Date Monday, March 31, 2025 All job postings expire at 12:01 AM on the posting expiration date. Please note that in order to be considered for this position, you must possess all of the basic/required qualifications. Privacy Do Not Sell My Personal Information (CA) Terms of Use Accessibility

The Director, State Government Affairs serves as an advocate for CareSource business priorities and Medicaid & Medicare managed care on a state level. Essential Functions: Develop, implement and lead a strategic approach to advocacy efforts and coordinate, facilitate and advance business leadership priorities at the state level Serve as primary liaison between CareSource and state elected officials, administration members and other key state organizations Develop and implement an effective government affairs program in our strategic states to position CareSource and its health plans in a positive manner with key governmental stakeholders and to further its mission and strategic objectives Collaborate with state trade associations on key policy issues and aligned advocacy objectives Develop and implement strategic advocacy strategies in conjunction with the marketing and community services staff, to support and advance corporate strategic goals Monitor and research emerging industry, policy and regulatory changes at state levels for analysis and integration into the corporate business development plan Participate in the development of key partnerships with external agencies, associations and consumer advocacy coalitions and other external stakeholders Lead/manage contract lobby resources in various states Participate in the development of the annual strategy for the corporate PAC to effectively support and protect issues critical to CareSource' interests Perform any other job duties as requested Education and Experience: Bachelor's degree in health/public policy, public administration, business administration or related field or equivalent work experience is required Relevant master's degree in health policy, public policy, public administration or other related discipline or equivalent work experience is preferred Minimum of five (5) years of senior leadership experience in public sector/not-for-profit policy development and advocacy is required Minimum of three (3) years planning and strategy development experience is required Minimum three (3) years of experience with Medicaid & Medicare managed care and other public health care programs is required Competencies, Knowledge and Skills: Thorough understanding of legislative processes at local, state and federal levels and lobbying experience with a primary concentration in policy legislative issues Strong working knowledge of Medicaid , Medicare and managed care laws, regulations and financing models Intermediate proficiency level with Microsoft Office Broad internet research skills Technical writing skills Excellent written and oral communications skills Legislative advocacy skills Understanding of the public policy process Strategic thinker with negotiation skills Strong analytic, research and organizational skills Knowledge and experience with publicly funded health care programs Licensure and Certification: Certified Healthcare Insurance Executive (CHIE) is preferred Working Conditions: General office environment; may be required to sit or stand for extended periods of time Ability to travel as required by the needs of the business Compensation Range: $110,800.00 - $193,800.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. Compensation Type (hourly/salary): Salary Organization Level Competencies Create an Inclusive Environment Cultivate Partnerships Develop Self and Others Drive Execution Influence Others Pursue Personal Excellence Understand the Business This is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an inclusive environment that welcomes and supports individuals of all backgrounds.

The Opportunity: A Fortune 500 telecommunications company is seeking an experienced Regulatory Specialist on a long-term, temporary basis. The assignment is expected to last at least six months, possibly longer and the position is remote. If a remote candidate is near one of the company's national locations, the candidate may be required to be in-person for training and/or meetings. The hourly rate is up to $40 plus benefits. Primary Duties The Regulatory Specialist is responsible for preparing and filing FCC/FAA applications and documentation related to tower erection, modifications, and antenna installations. Additional duties include the following: Reviewing and ensuring compliance with federal, state, and company regulations, managing regulatory filings, maintaining relationships with FCC/FAA personnel. Overseeing the approval process for tower projects. The role requires Analyzing and responding to regulatory inquiries, assembling accurate documentation for compliance, and staying updated on relevant guidelines (e.g., FAA, FCC, NEPA). Requirements: Bachelor's degree or equivalent experience. At least two years of experience in regulatory compliance. Knowledge of the wireless communications industry, government procedures, and regulatory requirements. Proficiency in preparing/ reviewing FAA and FCC forms and regulatory documentation. Strong communication, organizational, and interpersonal skills. Experience in pre-construction evaluation, permitting, and NEPA review. The Partnership - Benefits: ABA-MEC Medical Benefit PEP 401k Paid Time Off Employee Assistance Program (EAP), Working Advantage {discounts), and Financial Wellness Program (FinFit) Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.