Regulatory Compliance M

Head of Regulatory Affairs - Global | Medical Device Scale-Up | London / West Sussex (Hybrid)

Salary: £100k+ & Bonus & Benefits

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'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.

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.

• Own and lead the Quality Management System (ISO 13485) and all regulatory activity across the business.
• 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.
• Translate the regulatory framework for a leadership team who need to understand it but don't live in it.
• Build processes that are robust enough to satisfy an auditor but lean enough to suit a company that's still moving fast.
• Know when something is a genuine compliance hard line and when there's a pragmatic path through — and have the credibility to make that call.
• 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.
• 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.
• Willingness to travel within the UK and to the US as the role requires, including occasional overnight and international travel.

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.

Direct access to the CEO — you'll report straight in, and regulatory will have a seat at the table.

A growing, ambitious business with global reach.

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.