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Regulatory Affairs Specialist skills for your resume and career

Updated January 8, 2025

6 min read

Regulatory Affairs Specialist Example Skills

Below we've compiled a list of the most critical regulatory affairs specialist skills. We ranked the top skills for regulatory affairs specialists based on the percentage of resumes they appeared on. For example, 10.1% of regulatory affairs specialist resumes contained regulatory affairs as a skill. Continue reading to find out what skills a regulatory affairs specialist needs to be successful in the workplace.

15 regulatory affairs specialist skills for your resume and career

1. Regulatory Affairs

Regulatory affairs entail a set of rules, regulations, and enforcement guiding the operations and conduct of a company business, organization, or association.

Here's how regulatory affairs specialists use regulatory affairs:

Provide strategic direction and operational management of the Regulatory Affairs and Compliance staff in order to successfully navigate the regulatory process.
Developed procedure and work request form for incoming projects to the Regulatory Affairs department which enabled improved progress monitoring and follow-up.

2. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how regulatory affairs specialists use fda:

Work collaboratively with the Purchasing Department to review raw material specifications and FDA declarations from suppliers to assist in approving suppliers.
Assist in implementation of new business processes created to meet FDA regulations and guidance regarding electronic standards for regulatory information.

3. Regulatory Agencies

A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.

Here's how regulatory affairs specialists use regulatory agencies:

Interacted with International affiliates/Distributors and representatives of regulatory agencies.
Uploaded chemical disclosures to FracFocus and NMOCD, supporting voluntary chemical completion usage disclosures, and maintaining compliance with regulatory agencies.

4. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how regulatory affairs specialists use medical devices:

Evaluate the compatibility of trauma reconstructive orthopedic medical devices across multiple device classes and product lines.
Manage the ever evolving and complex regulatory requirements for medical devices in Latin American countries.

5. Regulatory Compliance

Here's how regulatory affairs specialists use regulatory compliance:

Review and approve device labeling as well as scientific and promotional materials; also documentation change requests to ensure regulatory compliance.
Reviewed technical and clinical documentation and recommend changes for labeling, manufacturing, and clinical protocol for regulatory compliance.

6. Regulatory Submissions

Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.

Here's how regulatory affairs specialists use regulatory submissions:

Participate in decision making on regulatory submission issues using historical knowledge and FDA's current regulations on medical device industry.
Coordinated and prepared documents for Regulatory submission and prepared the plan for all other surveillance activities of oversight agencies.

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7. Patients

Here's how regulatory affairs specialists use patients:

Established personal relationships with patients to ensure study protocols were correctly implemented, alleviating any concerns as necessary.
Drafted consents/releases for patients to participate in specific studies for clinical trial participation.

Select Skills To Add To Your Resume

Regulatory Affairs

FDA

Regulatory Agencies

Medical Devices

Regulatory Compliance

Regulatory Submissions

8. Excellent Interpersonal

Here's how regulatory affairs specialists use excellent interpersonal:

Use excellent interpersonal communication skills to work cross-functionally with departments to produce filings before deadlines.

9. Regulatory Authorities

Regulatory authorities refer to the government organizations created to oversee the policies and procedures enforced in various branches of law. Some examples of these include the Food and Drug Administration, the Federal Trade Commission, and the Bureau of Alcohol, Tobacco, and Firearms. Each of these administrations ensures health and safety regulations put in place by the government are enforced in all appropriate situations.

Here's how regulatory affairs specialists use regulatory authorities:

Interact with representatives of domestic and international partners, subsidiaries and international regulatory authorities to discuss regulatory issues and submission requirements.
Assisted regulatory authorities to resolve product acceptance issues, and resolved potential conflicts between installation codes and UL requirements.

10. Regulatory Issues

Regulatory Issues refer to the potential risks that local legislations or regulations will change, which businesses must conform to. If a business does not comply with the changes made, there could be cause for legal action. Examples of regulatory issues include new stimulus bills, changes to workers' leave, and reforms to overarching issues such as healthcare.

Here's how regulatory affairs specialists use regulatory issues:

Supported Company position and the successful outcome of these and other regulatory issues and dockets through outstanding execution and management.
Designed and distributed quarterly internal e-newsletter to communicate potential regulatory issues across functional areas of the company.

11. EU

Here's how regulatory affairs specialists use eu:

Provide regulatory intelligence involving review and interpretation of US and EU regulations and guidelines for internal project teams.
Prepared new technical documentation for EU, Canada and Australian product registration/submission.

12. Regulatory Strategies

Regulatory strategies depict the approaches used to control and implement effective policies relevant to resolving various human services issues. Regulatory strategies guide the development and implementation of policies that influence the quality of services offered to the public's members.

Here's how regulatory affairs specialists use regulatory strategies:

Provided input for regulatory requirements and regulatory strategies in cross-functional team meetings on product development to ensure timely submission and approval.
Coordinate regulatory strategies with an international regulatory counterpart to minimize the global impact of changes received through change control.

13. PMA

Here's how regulatory affairs specialists use pma:

Authored and prepared FDA submissions: PMA, PMA-S, Real time review, Device Defect reports, and Annual reports.
Experience with US FDA 510(k) and PMA submissions, validation of country registration procedures and database management.

14. Product Development

Product development is the complete procedure of creating a product from concept until release of the final product. Product development has many stages after which a product is released into the market. Identifying the need, creating the opportunity, conceptualizing a product, and providing a solution, all are different stages of product development.

Here's how regulatory affairs specialists use product development:

Provided regulatory guidance to product development teams and drove strategic regulatory implementation via proper design controls throughout the product development process.
Develop solutions in collaboration with Product Development, as well as Science and Merchandising departments, to support necessary requirements.

15. ISO

Here's how regulatory affairs specialists use iso:

Lead Meetings and directed and performed Corrective Actions and Material Review Reports according to ISO international standard organization regulations
Map all ISO filings for NE and NJ companies on both auto and property from the new FISERV Matrix system.

12 Regulatory Affairs Specialist Resume Examples

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Tyler Murphy Regulatory Affairs Specialist Contact Information San Diego, CA (780) 555-3860 tmurphy@example.com Skills • Procedures • Process Validation • FDA • Financial Statements • Communication • Product Development • Regulatory Issues • Quality Procedures • Utility Systems • CFR Employment History Regulatory Affairs Specialist 2020 - Present Pfizer San Diego, CA • Follow up progress on regulatory submissions with PCO countries. • Led the successful transfer of the entire Caribbean Regulatory activities to Costa Rica Operations. • Communicated with Pfizer local country regulatory colleagues to determine regulatory requirements and CMC needs for global clinical submissions. • Review the contents of such documents prior to submission to FDA to ensure their completeness. • Reviewed / approved site procedures, validation protocols /reports. Quality Assurance Auditor 2015 - 2020 Kaiser Permanente Santa Clara, CA • Reviewed all policies and procedures for compliance with local, State, and federal regulations. • Created monthly reports for each facility's Medical Staff Board to measure core competencies and improve overall patient satisfaction. • Communicated with global entities to facilitate investigations and compliance with corporate procedures. • Evaluated current operating procedures from a three dimensional aspect. Validation Specialist 2014 - 2015 Intel Santa Clara, CA • Tool was C-based, XML driven, and ran under Linux. • Monitored and ran hardware tests for Intel 6th Gen chipset Modified and developed python scripts to help automate testing • Tested bleeding edge technologies and software with Intel hardware. • Created Validation Summary Report (VSR) to summarize overall validation activities. Education Bachelor's Degree Business 2006 - 2009 San Jose State University San Jose, CA


Bryan Sanders Regulatory Affairs Specialist Contact Info Round Lake, IL (520) 555-9613 bsanders@example.com Skills QCInternal DatabaseRegulatory SupportCounselProceduresDossiersRegulatory AgenciesRegulatory IssuesAdministrative FunctionsStudy Protocol Employment History Regulatory Affairs Specialist 2019 - Present Baxter Regional Medical Center Round Lake, IL • Developed and implemented regulatory strategies for electronic submissions to agencies in U.S. and Europe. • Maintain electronic and historical regulatory files of submissions to regulatory authorities in accordance with record retention guidelines. • Collaborate with 3rd party companies for US regulatory submissions. • Manage regulatory activities relating to the company core safety information for base solutions in the Baxter's Fluid Systems franchise. Regulatory Administrator 2018 - 2019 JPMorgan Chase Chandler, AZ • Reset passwords for Midrange, Windows, Unix, and Mainframe accounts • Train new employees as well as current employees from other platforms on the procedure for processing requests on the UNIX platform. • Configured VMware and installed several Linux and Windows Operating Systems according to the client needs. • Installed and configured TIBCO EMS servers on developer's workstations and UNIX machines. • Administer users, connections, roles and permissions via Informatica and within Unix. Study Coordinator 2017 - 2018 Premier Chandler, AZ • Acted as the point person for end of study data reconciliation with the CRO and clinical sites. • Collaborated with clients and consultants to change and improve protocols. • Maintained the trial master file and ensured a high level of quality for all study documents. • Supervised and conducted data collection. • Act as liaison between research and data collection staff. Education Bachelor's Degree Business 2009 - 2012 American InterContinental University Chandler, AZ


Jerry Austin Regulatory Affairs Specialist Arlington, TX jaustin@example.com (650) 555-9179 Experience Regulatory Affairs Specialist 2019 - Present AlconArlington, TX • Prepare and submit: annual reports, post approval supplemental applications for solid oral and liquid dosage forms. • Prepare responses to FDA questions and other regulatory correspondence. Quality Assurance Specialist 2018 - 2019 General MotorsArlington, TX • Developed Quality procedures, processes / work instructions. • Support Launch Leader as needed, producing reports from internal tracking system as well as PowerPoint presentations. • Created the quality culture that lead to an ISO 9000 certification on the first try. • Perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used for the manufacturing. • Assisted to develop the Document Control system for the Pharma Group. Validation Specialist 2017 - 2018 General MotorsArlington, TX • Tested completed equipment during different driving scenarios at the Milford Proving Ground facility. • Managed resources and validation activities for the team. • Manage all validation activities being performed by suppliers for MY2000 GMT800 program. • Executed ADV plans by initiating and monitoring tests to scheduled completion and conducted design reviews based on test results. Skills Process Validation Safety Reports Firmware Osha Powerpoint Action Plans Procedures USP Quality Checks Management System Education Bachelor's Degree Chemistry 2009 - 2012 Texas A&M UniversityCollege Station, TX


Richard Andrews Regulatory Affairs Specialist Employment History Regulatory Affairs Specialist 2014 - Present CARDIMASan Jose, CA • Mentored new employees and conducted training on regulatory procedures. • Planned and executed Regulatory strategies for domestic and international manufacturing site transfers. • Keep current with Medicaid/Medicare, and Worker's Compensation policies and procedures. • Prepare regulatory submissions to secure timely approvals in support of business initiatives. • Interfaced with the FDA and Consumer Product Safety Commission (CPSC) via teleconferences and face-to-face meetings. • Designed and distributed quarterly internal e-newsletter to communicate potential regulatory issues across functional areas of the company. Regulatory Affairs Specialist 2009 - 2014 Intuitive SurgicalSan Jose, CA • Contribute a regulatory perspective to product development teams. • Prepare documents, as directed, for internal use or submission to regulatory authorities. • Prepare local labeling deviation forms, based on queries from the Health Authorities. • Provided regulatory support for new and ongoing research studies including filings, document creation and maintenance. Clinical Research Assistant 2007 - 2009 ClinimetricsSan Jose, CA • Communicate with sponsors, site and Clinimetrics colleagues to ensure effective project management. • Maintain and track study data (enrollment and CRF collection). • Conducted literature reviews for two aging and home health care projects. • Assisted the PI and others on developing and writing original research projects with the goal of publication. Education Bachelor's Degree Business 2004 - 2007 San Jose State UniversitySan Jose, CA Contact Information San Jose, CA (660) 555-3878 randrews@example.com Skills State Agencies Regulatory Submissions Regulatory Authorities Research Projects Study Protocol Data Management MRI CPR Promotional Materials Medical Records


Scott Wilson Regulatory Affairs Specialist Warsaw, IN (290) 555-3303 swilson@example.com Skills A/B Regulatory Changes Business Units ROI Product Demand Product Development Special Projects Real Estate Regulatory Strategies Research Projects Employment History Regulatory Affairs Specialist 2017 - Present Zimmer BiometWarsaw, IN • Aided in development of regulatory strategy for remediation project for Zimmer Biomet. • Write, prepare, and submit medical device and manufacturer registration application dossiers to the governments of India and Taiwan. • Managed regulatory projects, coordinating regulatory related activities and provided regulatory supports for sterile/non-sterile products, small and monoclonal antibodies molecules. • Scanned and imported PDF renditions of regulatory submissions into the Documentum database. Marketing Analyst 2016 - 2017 JPMorgan ChaseColumbus, OH • Achieved optimal PPC results by continual optimization of budget and campaigns. • Gained advanced knowledge on Underwriting procedures specific to Independent Foreclosure Review process. • Relay appropriate resolutions to specify government agencies such as Deloitte and Touch consulting as appropriate. • Developed and executed marketing collateral for new product launches, customer case studies, and web copy. Market Research Analyst 2014 - 2016 JPMorgan ChaseColumbus, OH • Promoted as an Archivist to reopen completed cases to ensure it adheres to the procedures and compliance. • Performed OFAC related investigations on entities as well as its directors among other determinations according to USA PATRIOT Act. • Assisted with the development, design, and input process for new procedures related to modification and foreclosure complaints. • Developed in-house database, analyzed market research to recommend marketing tools. Education Bachelor's Degree Business 2011 - 2014 Ohio State UniversityColumbus, OH


Susan Cox Regulatory Affairs Specialist Charlotte, NC (450) 555-7707 scox@example.com Experience: Regulatory Affairs Specialist Bank of America Charlotte, NC 2011 - Present • Developed and updated departmental procedures, ensuring the team s payment posting processes are compliant with the most current company policies. • Help create procedures and document the regulatory filing process to enhance efficiency of filings. • Reviewed and approved labels, revised to meet ISBT 128 standards, for successful submission to FDA. • Developed new and revise current processes and standard operating procedures. • Coordinate meetings with KPMG to evaluate best practices and meet with department heads to implement procedures while maintaining meeting minutes. • Managed several projects with a regulatory submissions focus. Regulatory Administrator Bank of America Charlotte, NC 2009 - 2011 • Experienced on Maintaining & troubleshooting SAN and Fiber Channel Card related on LINUX and UNIX Operating systems. • Root cause analysis after Panic/Dump/Crash related to Linux and Solaris by co-coordinating with Vendors for permanent resolution. • Verify and investigate consumer complaints and respond to them with the regulatory agencies. • Create and update department procedures Demonstrate the technical ability to perform server UNIX commands Maintaining audio fidelity of the call. Regulatory Affairs Associate Pepco Holdings College Park, MD 2002 - 2009 • Support the Company's business plan through the development of cost of service studies for regulatory proceedings and regulatory filings. • Participated in all aspects of the production and review of daily, monthly, quarterly, and semi-annual Regulatory Filings. • Update regulatory technical files and review documentation and preparation of regulatory and associated dossiers. • Prepared all initial regulatory submissions, protocol amendments and continuing review reports submissions to their appropriate regulatory authority agency. • Participate in coordinating all aspects of regulatory submissions and responses and regulatory management of reformulation products. Skills • Project Management • ISO • Quality Standards • Regulatory Agencies • State Regulations • Regulatory Issues • Regulatory Information • Institutional Review • Product Development • Regulatory Submissions Education: Bachelor's Degree University of Maryland - College Park College Park, MD 1994 - 1997 • Major: Biology


Roger Morris Regulatory Affairs Specialist Greenville, SC (220) 555-0829 rmorris@example.com Experience: 2016 - Present Regulatory Affairs Specialist / Pharmaceutical Associates / Greenville, SC • Gathered and evaluated regulatory documents for various drugs for submissions to the FDA. • Review and organize package insert revisions prior to FDA submission for content and accuracy. • Monitor progress of product development projects 2011 - 2016 Document Control Specialist / Jacobs Engineering Group / Greenville, SC • Reviewed and issued transmittals to suppliers and validate supplier pick-up for Iso's. • Served as the SharePoint Site Administrator and Trainer for users, both internal and external. • Complied with company policies, practices and procedures. • Manage Prolog for the procurement and Construction Departments for purchase orders, and monitoring and tracking site documentation. 2009 - 2011 Quality Assurance Administrator / United States Marine / Jacksonville, NC • Converted a plant from non-ISO manufacturing to an ISO certification plant in 5 months. • Worked in an USDA, inspected contract Co-Packaging plant that produced ready to eat products. • Assisted QA Manager in testing and performing lab testing on new lab equipment, and/ or procedures. Skills: Safety Program, ISO, Regulatory Submissions, Administrative Tasks, Sarbanes-Oxley, Quality System, Capa, Ensure Compliance, Jenkins, Protocols Education: 2000 - 2003 Bachelor's Degree Business / Liberty University / Lynchburg, VA


Lawrence Hamilton Regulatory Affairs Specialist Andover, MA \| (990) 555-1675 \| lhamilton@example.com Work Experience Regulatory Affairs Specialist, Pfizer - Andover, MA 2018 - Present Prepared post-marketing drug safety reports for the FDA and for international subsidiaries to file with the relevant agencies. Follow up progress on regulatory submissions with PCO countries. Experienced in new product development core teams and created technical regulatory strategies. Market Analyst, CoStar Group - San Diego, CA 2017 - 2018 Provided research, analysis and projections in real estate markets for the nation's leading provider in commercial real estate information. Cultivate relationships with commercial real estate professionals such as brokers, appraisers and developers. Collected and analyzed secondary data relevant to research projects. Market Research Analyst, CoStar Group - San Diego, CA 2007 - 2017 Contributed marketing insight to focus groups that improved company metrics for research. Lead and inspire a team of 6-8 researchers according to established processes and procedures. Machined and assembled components; wired sensors and cameras for data collection Skills Online Surveys, Ensure Compliance, Market Data Services, Facility, Healthcare, Financial Statements, Focus Groups, Market Research, Competitive Analysis, Regulatory Strategies Education Bachelor's Degree Business 2004 - 2007 Ashford University - San Diego, CA


Frances Grant Regulatory Affairs Specialist Parsippany-Troy Hills, NJ (990) 555-3578 fgrant@example.com Experience Regulatory Affairs Specialist, Zimmer Biomet, Parsippany-Troy Hills, NJ 2014 - Present • Aided in development of regulatory strategy for remediation project for Zimmer Biomet. • Contribute a regulatory perspective to product development teams. Public Affairs Assistant, Ogilvy, New York, NY 2012 - 2014 • Develop public relations campaigns for ethnic markets. • Prepared scheduled reports, summaries, speeches, presentations and press releases. • Initiated community outreach programs to language assess among minority populations in the U.S. • Responded to inquiries from the public and the media is another duty of the public affairs specialist. Public Affairs Internship, Ogilvy, New York, NY 2011 - 2012 • Press Releases Artists Media Arrangement Tour Schedule Management Data Storage Management • Assisted account executives and public affairs team on client-related tasks, including expanding media contact list and conducting media outreach. Skills • Public Policy • Community Relations • MDD • Product Development • Public Affairs • Internship Program • Policy Analysis • Regulatory Issues • Twitter • FDA Education 2008 - 2011 Bachelor's Degree Law, The John Marshall Law School Chicago, IL


Janice Peterson Regulatory Affairs Specialist Silver Spring, MD \| (260) 555-5195 \| jpeterson@example.com Employment History: Verizon - Silver Spring, MD 2017 - Present Regulatory Affairs Specialist • Create regulatory toolkits and guidance documents for all regional network employees and staff. • Provided regulatory input/perspective to internal/external clients on regulatory issues. • Established strong working relationships with Commission staff and advocated for regulatory issues beneficial to the company. Apple - Washington, DC 2013 - 2017 Data Specialist • Engaged clients by demonstrating Apple hardware, software, and services. • Facilitated occasional training sessions and participated in camps/workshops focused on Apple products and software. • Worked with clients to help integrate Apple technology into their own small businesses. • Developed long term relations with large customer Specilist in communication of products. Apple - Washington, DC 2010 - 2013 Reporting Specialist • Assisted HR manager in interviewing and hiring other Specialists. • Named Apple Credo Award Winner in 2009 based on work ethic, leadership and excellent customer service. • Transact POS sales, keyboard exchanges, and data transfers. Skills: Applicable Laws, Setup, ERP, Customer Data, Data Support, Regulatory Issues, Internet, Confidential Information, Data Base, FDA Education: Georgetown University - Washington, DC 2002 - 2005 Bachelor's Degree Law


Emily Baker Regulatory Affairs Specialist phone(520) 555-9227 addressBellingham, WA emailebaker@example.com Experience 2018 - Present Regulatory Affairs Specialist Alpha Technologies · Bellingham, WA • Managed and directed technical activities including basic research, product development, and support for field Technical Service Group. • Maintained EPA standards and regulations under the Toxic Substance Control Act (TSCA) for new and developing polyurethane product chemistries • Prepare and compiled regulatory submissions and CTDs to Regulatory Authorities in accordance with internal business processes and regulatory requirements. • Coordinated efforts associated with preparation of regulatory dossiers. • Ensured audit compliance and site inspection readiness to ISO 13485 and 21 CFR 820 QMS. 2016 - 2018 Document Control Specialist Alpha Technologies · Bellingham, WA • Researched and saved data and specifications from the Intranet for componentinformation creating them into PDF format. • Created, processed and maintained Parts Submission Warrant (PSW) database for all business. • Selected Contributions: Wrote Standard Operating Documents and Procedures for processes within the company. 2009 - 2016 Quality Assurance Administrator Post Holdings · Bellingham, WA • Worked closely with USDA personnel. • Draft quality assurance policies and procedures Interpret and implement quality assurance standards. • Developed, and trained the Quality Department, direct reports (i.e. • Utilize Sharepoint site for documentation of investigation findings and appropriate CAPA's. • Received raw materials to be identified by lot numbers, entered into (IQS) • Provided information and guidance on compliance, regulations, policies, and procedures. Skills • ISO • Quality Standards • Regulatory Strategies • Engineering Drawings • Regulatory Agencies • CAD • Training Records • Document Control Procedures • Protocols • Project Procedures Education 2000 - 2003 Bachelor's Degree Business Western Washington University · Bellingham, WA


Denise Tucker Regulatory Affairs Specialist phone:(490) 555-7243 email:dtucker@example.com address:Boston, MA Employment History Regulatory Affairs Specialist 2020 - Present Boston Scientific · Boston, MA • Provide support for preparation and submission of regulatory FDA annual reports, as needed. • Submit cardiovascular medical device information to the FDA. • Maintained PMA/510K submissions and supplement files, dossiers and Japanese regulator files. • Communicate submission requirements to internal customers such as product development or manufacturing area teams. • Prepared post-marketing drug safety reports for the FDA and for international subsidiaries to file with the relevant agencies. Examiner 2018 - 2020 EMSI Examination Management Services · Jacksonville, FL • Performed basic biometric measurements (height, weight, blood pressure) and blood samples. • Blood and urine collections, vitals, EKG's, centrifuging and processing of all specimens, heavy paperwork. • Collected blood and urine specimens, EKG's, height, weight, blood pressure, pulse. • Preformed mobile insurance exams, including medical histories, measurements, lab draws and EKG. • Collected approximately 10,000 blood samples. Finance Compliance Examiner 2015 - 2018 Federal Deposit Insurance · Irvine, CA • Used Excel spreadsheets to record data/files reviewed during compliance examinations. • Completed the written FDIC Report of Examination. • Reviewed borrowers' financial statements and cash flows, as well as the bank's collateral positions on sampled loans. • Conducted compliance examinations to assess bank's compliance management systems, and assessed systemic and operational risk exposure. Skills FDA Regulatory Issues Institutional Review Regulatory Activities Examination Findings Community Agencies Health History Communication Oversight Ensure Compliance Education Bachelor's Degree Business 2012 - 2015 California State University - San Bernardino · San Bernardino, CA

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List of regulatory affairs specialist skills to add to your resume

The most important skills for a regulatory affairs specialist resume and required skills for a regulatory affairs specialist to have include:

Regulatory Affairs
FDA
Regulatory Agencies
Medical Devices
Regulatory Compliance
Regulatory Submissions
Patients
Excellent Interpersonal
Regulatory Authorities
Regulatory Issues
EU
Regulatory Strategies
PMA
Product Development
ISO
Regulatory Support
Dossiers

MDR
Regulatory Filings
IRB
Clinical Trials
III
International Regulations
GCP
Regulatory Guidance
Informed Consent
Product Registrations
MDD
CFR
Management System
QA
GMP
Safety Reports
Lifecycle Management

ICH
Internal Audit
Oncology
Promotional Materials
Pharmaceutical Industry
Consent Forms
Federal Regulations
ECTD
SharePoint
HIPAA
Data Entry
Institutional Review
Strong Analytical
Government Agencies
External Audits

Updated January 8, 2025

Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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