Head of Regulatory Affairs - Global | Medical Device Scale-Up | London / West Sussex (Hybrid)
The Role in 20 Seconds
You've spent your career owning regulatory and quality for medical devices — and crucially, you've done it across both sides of the Atlantic. You know EU MDR and CE marking inside out, and you've personally driven US FDA submissions, 510(k)s included, recently enough that you'd be comfortable doing it again on day one. You've probably held titles like Head of RA/QA, Director of Regulatory Affairs, or VP Regulatory. You're as happy hosting a Notified Body audit as you are sitting with engineers on electrical safety, EMC and software validation. You don't need a large team behind you to make things happen — you've been the person the business relies on to get the device certified and keep it certified.
If that's you, and a build‑phase medtech environment excites rather than unsettles you, keep reading.
The Company
A fast‑growing medical device company developing genuinely novel technology in the oncology space — the kind of innovation that changes how a major area of patient care is delivered. They've moved beyond the earliest stage: the product is real, the ambition is global, and the regulatory pathway is now front and centre. This is a company where regulatory leadership isn't a back‑office function — it's on the critical path to getting a life‑changing product to patients.
The company will not be named at this stage. I'm happy to share the full picture in a confidential conversation.
What You'll Actually Do
The core of it:
- Own and lead the Quality Management System (ISO 13485) and all regulatory activity across the business
- Drive the EU MDR conformity assessment process through to CE mark, and lead US FDA submissions (510(k) and the wider approval pathway) — hands‑on, not just in oversight
- Act as the Person Responsible for Regulatory Compliance and the management representative for the QMS
- Lead engagement with global regulatory authorities and Notified Bodies — owning the relationships, not just supporting them
- Build regulatory and quality evidence across all device disciplines: mechanical, electrical, electronic and software
- Manage external design and contract manufacturing partners on quality agreements, auditing and supplier control
- Own post‑market surveillance, vigilance, CAPA, risk management and design review
The less obvious bits that matter just as much:
- Being the person who can translate the regulatory framework for a leadership team who need to understand it but don't live in it
- Building processes that are robust enough to satisfy an auditor but lean enough to suit a company that's still moving fast
- Knowing when something is a genuine compliance hard line and when there's a pragmatic path through — and having the credibility to make that call
Who We're Looking For
You'll be a natural fit if:
- You've managed an ISO 13485 QMS under MDD/MDR for device development and/or manufacturing in the UK/EU — this is essential
- You've taken devices through EU MDR conformity assessment to CE mark — essential
- You have genuine, reasonably recent hands‑on US FDA experience, including 510(k) — this is a real requirement, not a nice‑to‑have, and current familiarity with how submissions are actually filed today matters
- Your regulatory expertise spans all device types, not just one engineering discipline — you're comfortable across electrical, software and mechanical evidence
- You've held formally defined regulatory roles (PRRC, Responsible Person, management representative) and led authority and Notified Body interactions directly
- Experience of Class I and II devices, and of working with external contract design and manufacturing organisations — essential
- You've operated in a scale‑up or SME and you understand what that means: ambiguity, shifting priorities, and wearing more than one hat
- Demonstrable regulatory leadership in medical devices, with both EU MDR and US FDA experience
- Direct experience leading audits and authority engagement
- Excellent attention to detail and the judgement to know what matters most
- A self‑starter who's motivated by getting the product to market, not by the size of the team reporting to them
- Willingness to travel within the UK and to the US as the role requires, including occasional overnight and international travel
What's Actually In It For You
- The chance to own the regulatory and quality function for a product that genuinely matters — in a company at the point where your work is the difference between a great device and a great device patients can actually access
- A genuinely novel technology in a high‑profile area of medicine
- Direct access to the CEO — you'll report straight in, and regulatory will have a seat at the table
- The opportunity to build and shape the function, not inherit someone else's
- A growing, ambitious business with global reach
The Honest Bit
This is a scale‑up, and that means the function is still being built. If you've spent your whole career in a large, mature medtech business where every process is documented, every resource is in place, and the regulatory pathway is already paved, this will be a bigger step than it looks on paper. If, on the other hand, you've thrived where you had to make the judgement calls yourself and build things properly from the ground up, you'll find this energising.
A note on FDA, because it matters: this role genuinely needs someone who has not only done ISO but also US submissions hands‑on and recently. If your FDA work is strong but a little while ago, it's still worth a conversation — but be ready to talk honestly about how current you are.
Apply via the link, or message Andy Clarke directly if you'd rather have a conversation first — especially if you're weighing up whether your FDA and MDR balance is the right fit.
Andy has been in and around medtech and healthcare for over twenty‑five years, including building and selling medtech companies. You'll get a straight answer to a straight question.
All applications are treated in the strictest confidence.
