Regulatory Affairs Specialist CV Example & Template
A complete two-page CV for a regulatory affairs specialist in UK medical devices, followed by what regulatory directors and recruiters check first. Use the structure, then replace the products, markets, submissions and standards with your own, since employers read for the exact frameworks you have worked under.
Last reviewed October 2026
Example Regulatory Affairs Specialist CV
Sofia Marchetti
Regulatory Affairs Specialist, medical devices (UK, EU and US)
Cambridge, UK
Profile
Regulatory affairs specialist with six years in medical devices, covering Class IIa and IIb products under the EU MDR and UK MDR 2002. I have prepared technical documentation for 9 products, handled two notified body audits and supported one US 510(k). I write clearly, track rule changes and work closely with quality and clinical teams. Looking for a senior specialist role in a growing device or diagnostics company.
Experience
Regulatory Affairs Specialist
Apr 2022 – Present
Fenwick Medical Devices · Cambridge
- Prepared and updated the technical documentation for 9 Class IIa and IIb devices under the EU MDR, with no major nonconformities at the last notified body audit.
- Led UK registration with the MHRA for 6 products, and kept the UKCA and CE marking plan current as transition dates changed.
- Supported a US 510(k) submission for a Class II device, writing the substantial equivalence section and answering two FDA questions within the deadline.
- Built a regulatory intelligence tracker covering MHRA, EU and FDA updates, and flagged 11 changes in 2024 that needed product or labelling action.
- Review labelling, instructions for use and marketing claims before release, and cut average review time from five days to two.
Regulatory Affairs Associate
Sep 2019 – Mar 2022
Arden Diagnostics · Oxford
- Maintained technical files for 14 in vitro diagnostic products and prepared change notifications for the notified body.
- Contributed to the gap assessment against the IVDR, which set priorities for risk management and performance evaluation updates.
- Managed document control for the regulatory team, including 60 controlled documents with version history and review dates.
- Handled post-market surveillance data and vigilance reports with the quality team, and tracked complaints for trends each quarter.
Quality and Regulatory Assistant
Aug 2018 – Aug 2019
Pellham Healthcare · Reading
- Supported an ISO 13485 surveillance audit by pulling records, tracing CAPAs and answering auditors' questions.
- Drafted standard operating procedures for supplier approval and labelling control.
- Entered and checked product data in the UDI database before registration deadlines.
Education
MSc Biomedical Engineering
2016 – 2018
University of Cambridge
Dissertation on risk management for wearable monitoring devices
BEng (Hons) Biomedical Engineering, 2:1
2012 – 2016
University of Bath
Skills
EU MDR and UK MDR 2002 · Technical documentation · MHRA registration · FDA 510(k) support · ISO 13485 and ISO 14971 · Regulatory intelligence · Labelling and claims review · Post-market surveillance · CAPA and document control · Notified body audits · Clinical evaluation input · Cross-functional communication
Professional memberships
- Member of TOPRA, the Organisation for Professionals in Regulatory Affairs
Training
- ISO 13485 internal auditor course, 2021
- IVDR implementation workshop, 2023
Why this Regulatory Affairs Specialist CV works: what shortlisters check first
The frameworks you have worked under
Regulatory hiring is specific. Name the regimes and standards you have actually worked with: EU MDR, IVDR, UK MDR 2002, FDA 510(k), ISO 13485 and ISO 14971. State the device class and the markets, because a Class I specialist and a Class III specialist are different hires.
Submissions with outcomes
Say what you prepared, where it went and what happened. Technical files updated, registrations completed, questions answered within a deadline and audits passed are all concrete. Avoid claiming sole credit for a submission that a team wrote, and describe the section you owned.
Regulatory intelligence and change
Rules in this field keep moving, with transition dates and new guidance from the MHRA, the EU and the FDA. Show how you track changes, what you did with them and how you told the business. One example of acting early beats a claim that you keep up to date.
Clear writing and document control
Reviewers and auditors read your documents, so employers look for precise, structured writing. Mention labelling review, technical file maintenance and procedures you wrote. Version control, traceability and consistent evidence count in a field where one gap can delay a launch.
Working with quality, clinical and product teams
Regulatory affairs sits between engineers, clinicians and auditors. Show who you worked with, how you agreed priorities and a time you said no to a claim or a change. Employers value people who protect the product and the timeline at once.
Key skills recruiters look for
How to write each section of a Regulatory Affairs Specialist CV
Profile
Open with your sector, device classes and markets, then one or two results such as submissions or audits passed. Mention the line of work you want next. Keep to four sentences and avoid generic lines about attention to detail.
Experience
Write bullets as product, regulation, action and result. Include the number of devices or files and the type of audit. Place the highest class or the most complex market first. Be careful with confidential details and describe products by type rather than by name.
Skills
Use the exact names of regulations and standards that appear in the advert, and keep versions current, for example EU MDR rather than the old directives. Add systems such as eQMS or document control tools. Cut vague items like regulatory knowledge.
Education and memberships
Give the degree and the subject. Life sciences, engineering and pharmacy are all common backgrounds. Add TOPRA membership or other regulatory affairs courses you have taken, and the date. Put audit or standards training near the top if the job needs it.
Format
Two pages, plain headings and a clear reverse chronological order. Use acronyms in full once, then the short form. Send a PDF and keep the layout simple so applicant systems read the standards and regulation names correctly.
More example bullet points
Strong Regulatory Affairs Specialist CVs lead with measurable impact. Here are examples of the kind of bullets that make recruiters stop scrolling:
Led FDA 510(k) submission for Class II medical device, securing clearance in 87 days — 40% faster than company average
Managed CE marking for 6 product lines across EU MDR transition, maintaining market access for €18M product portfolio with zero lapses
Established regulatory intelligence monitoring program identifying 14 upcoming rule changes, enabling proactive product updates 6 months ahead of deadlines
Relevant certifications
Common Regulatory Affairs Specialist CV mistakes
- Writing regulatory knowledge without naming a single regulation, standard or market.
- Leaving out device class, so the reader cannot judge the complexity of your work.
- Claiming a submission as your own when you wrote one section of it.
- Quoting outdated frameworks as current, such as the old directives instead of the MDR.
- Sharing confidential product names or audit findings from a past employer.
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How to tailor your Regulatory Affairs Specialist CV for each application
Every Regulatory Affairs Specialist job posting is different. The skills they prioritize, the seniority they expect, the setting — all of it shapes what your CV should emphasize. A CV that gets an interview at one employer can miss at another, even for the same job title.
The fastest way to tailor your CV is to paste the job description into NextCV. The AI reads the posting, maps it to your experience, and rewrites your bullets to match what the employer is scanning for. 1 free preview, no signup required — you only pay when you want a clean PDF download. Sign up free for 3 more.
Regulatory Affairs Specialist CV FAQ
What should a regulatory affairs specialist CV include?
A profile with your sector and markets, work history with submissions, audits and registrations, education, skills that name regulations and standards, and any professional membership. Two pages is enough for most posts.
Do I need a qualification to work in regulatory affairs?
Most people enter with a science, engineering or pharmacy degree and learn on the job. Extra qualifications help, such as a postgraduate course in regulatory affairs or a TOPRA qualification. Employers care most about the regimes you have worked with.
Should I list TOPRA on my CV?
Yes, if you are a member. TOPRA is a professional membership organisation for people working in regulatory affairs. Put it under professional memberships with your grade if you have one, and add any course you completed through it.
How do I move into regulatory affairs from a lab or quality job?
Show the overlap: audits, document control, CAPA, risk management and technical writing. Name the standards you know, such as ISO 13485 or GxP. Add a short course or a membership, and ask for the role at associate level if you have no submission experience.
How do I show regulatory work under NDA?
Describe the product type, the class and the market without naming the company or device. Use counts and outcomes, such as nine technical files or one clean audit. Interviewers accept general descriptions as long as the numbers are honest.