Regulatory Affairs Specialist with 5 years of experience preparing FDA submissions and maintaining compliance for Class II medical devices. Authored or co-authored 6 510(k) submissions cleared with an average of one additional information request. Brings precise technical writing, strong knowledge of FDA and EU MDR requirements and close work with engineering and quality teams.
Experience
Regulatory Affairs Specialist, Lumora Medical (Irvine, CA)
Aug 2022 – Present
Authored 4 510(k) submissions for Class II infusion and monitoring devices, all cleared within 140 review days
Compiled EU MDR technical documentation for 3 product families certified by the notified body on first review
Assess about 40 design and labeling changes a year for regulatory impact and letter-to-file decisions
Regulatory Affairs Associate, Pacific Orthopedic Devices (San Diego, CA)
Jan 2021 – Jul 2022
Co-authored 2 510(k) submissions for spinal implant systems
Filed 15 Medical Device Reports within FDA timelines
Education
M.S. in Regulatory Science, University of Southern California (Aug 2019 – Dec 2020)
Skills
Regulatory Submissions: 510(k), pre-submissions, EU MDR technical files, change assessments
Standards: 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, UDI requirements
Tools: eSTAR, GUDID, Veeva Vault RIM, Greenlight Guru
How to write a Regulatory Affairs Specialist resume
A strong Regulatory Affairs Specialist resume shows accuracy, risk reduction and the financial or legal outcomes you were accountable for. Lead with scope and impact: the size of the systems, budgets or teams you influenced, and the decisions you owned.
Sections, in order
Summary
Experience
Education
Skills
Certifications
Length: One page is ideal; two pages are fine with 10+ years of relevant experience.
Summary: Open with your specialty and years of experience, then one or two signature results.
Skills to feature
Financial modeling
FP&A
GAAP or IFRS
Audit and controls
Excel and SQL
ERP systems (NetSuite, SAP)
Contract drafting and review
Regulatory compliance
Risk assessment
Stakeholder reporting
Example bullet points
Shortened the monthly close from 10 to 5 business days by automating reconciliations in NetSuite
Built the three-statement model used in a $40M Series C, keeping forecast variance under 3%
Negotiated 120 vendor and customer contracts a year, cutting average review time from 9 to 4 days
Tips from recruiters
List licences and qualifications (CPA, CFA, bar admission) prominently; they are often hard filters.
Use a conservative, single-column layout; finance and legal readers value precision over style.
Quantify the scale you handled: revenue, assets, deal value or number of matters.
Recommended templates
Ledger (ATS-friendly): moderncv banking: accent name, bold dates on the right
Ivy (ATS-friendly): Harvard-style Times layout with centered headings
Classic (ATS-friendly): Jake's-style LaTeX classic: small caps and hairline rules
Regulatory Affairs Specialist resume FAQ
What should a Regulatory Affairs Specialist resume include?
A Regulatory Affairs Specialist resume should show accuracy, risk reduction and the financial or legal outcomes you were accountable for. Use these sections in this order: Summary, Experience, Education, Skills and Certifications. Lead with scope and impact: the size of the systems, budgets or teams you influenced, and the decisions you owned.
What is the best resume template for a Regulatory Affairs Specialist?
Ledger, Ivy and Classic work well for Regulatory Affairs Specialist roles. They are single-column with standard headings, so applicant tracking systems (ATS) parse them reliably.
How long should a Regulatory Affairs Specialist resume be?
One page is ideal; two pages are fine with 10+ years of relevant experience.
Which skills should a Regulatory Affairs Specialist put on a resume?
Prioritize the skills named in the job posting. Common ones for Regulatory Affairs Specialist roles are Financial modeling, FP&A, GAAP or IFRS, Audit and controls, Excel and SQL and ERP systems (NetSuite, SAP).
How do I write strong Regulatory Affairs Specialist resume bullet points?
Start with an action verb, say what you did, and end with a measurable result such as close time, forecast variance and savings. For example: "Shortened the monthly close from 10 to 5 business days by automating reconciliations in NetSuite."