Regulatory Affairs Specialist Resume Example

A strong regulatory affairs specialist resume demonstrates expertise in FDA regulations, submission preparation, and quality management systems. Highlight the number and types of submissions you've supported, regulatory pathways you've navigated, and any gaps you've closed in compliance or documentation.

Regulatory employers seek specialists who combine deep FDA and ICH knowledge with project management skills and the ability to build relationships across cross-functional teams. Your ability to interpret ambiguous regulations, anticipate reviewer questions, and navigate the submission process is critical to your value.

Also searched as

Senior Regulatory Affairs Specialist, Regulatory Coordinator

Rebecca Summers: Regulatory Affairs Specialist

San Diego, California, United States

Summary

Regulatory affairs specialist with 7 years guiding medical device companies through FDA submission processes, with 9 successful 510(k) and 2 PMA submissions resulting in approvals. Expert in 21 CFR Parts 11, 820, and 860, quality management system design, and international harmonization standards. Fluent in regulatory documentation, GCP, and FDA guidance interpretation.

Work Experience

Senior Regulatory Affairs Specialist, Coastal Medical Devices

Oct 2021 – Present. Medical device manufacturer with 180+ employees

• Led regulatory strategy and submission preparation for 4 medical devices across FDA 510(k) and De Novo pathways, achieving first-cycle approvals on 3 of 4 devices
• Designed and implemented quality management system compliant with 21 CFR Part 820, eliminating 7 prior audit findings
• Mentored 3 junior regulatory staff on FDA regulations and submission best practices, with 1 advancing to senior specialist role

Regulatory Affairs Specialist, MedTech Compliance Services

May 2019 – Sep 2021. Consulting firm supporting medical device submissions

• Prepared submissions for 6 medical device clients, including 510(k) applications, summary of safety and effectiveness reports, and predicate device justifications
• Conducted FDA audit readiness assessments for 8 device companies, identifying regulatory gaps and recommending corrective actions with 92% implementation rate
• Researched and summarized FDA guidance documents and warning letters, briefing clients on emerging compliance expectations and regulatory trends

Regulatory Coordinator, Pacific Healthcare Solutions

Aug 2017 – Apr 2019. Medical device startup focused on diagnostic products

• Supported preparation of first 510(k) submission for company's flagship device product, resulting in FDA clearance after 1 cycle
• Compiled regulatory documentation, including device design specifications, risk analysis, and validation study summaries
• Maintained regulatory documentation files and tracked regulatory communications with FDA

Education

California State University, San Diego

Master of Science, Regulatory Affairs. Aug 2017 – May 2019

University of California, San Diego

Bachelor of Science, Biomedical Engineering. Aug 2013 – May 2017

Skills

FDA regulations (21 CFR Parts 11, 820, 860), 510(k) submission preparation, PMA submission strategy, Quality management systems, ICH guidelines, Risk management (ISO 14971), GCP and GMP compliance, Technical writing and documentation, Regulatory project management, FDA interactions and negotiations, Device classification guidance

Languages

English, Portuguese

Certificates and Awards

• Regulatory Affairs Certification (RAC), RAPS, 2020
• Certified Quality Auditor, ASQ, 2021

Why this look works

Regulatory specialist resumes benefit from formal, authoritative formatting that reflects the precision and compliance demands of the role. Deep navy or charcoal tones convey regulatory rigor and trustworthiness. Clear section hierarchy and achievement-focused language demonstrate that you understand both regulatory complexity and business outcomes.

Resume tips for this job

• Quantify submission success: number of 510(k)s, PMAs, or IND approvals achieved, and note any first-cycle approvals or expedited timelines
• Highlight your specific FDA pathway expertise: 510(k), PMA, De Novo, IND, NDA; employers need specialists in their particular pathway
• Include regulatory certifications prominently: RAC certification from RAPS is the industry standard and signals serious regulatory expertise
• Mention quality management system experience if you have it, as QMS design knowledge is increasingly valued in regulatory roles

Common questions

Is a master's degree in regulatory affairs necessary, or can I advance with on-the-job training?

A master's in regulatory affairs is valuable and signals deep expertise, but it's not always required. Many specialists advance with strong bachelor's degrees in engineering or life sciences plus relevant industry experience. However, obtaining the RAC certification from RAPS is nearly essential for career advancement, regardless of education path. Combine solid industry experience with RAC certification to stand out.

How do I convey FDA knowledge on a resume without sounding overly technical?

Name the specific regulations and pathways you know: '21 CFR Part 820,' '510(k) submissions,' 'PMA strategy.' These terms are instantly recognized by regulatory employers. In achievement bullets, focus on outcomes rather than regulations: 'cleared 4 devices via 510(k)' or 'achieved first-cycle approvals on 3 of 4 submissions.' Let regulatory results speak for your technical knowledge.

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