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 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 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. Andy has been in and around medtech and healthcare for over twenty-five years, including building and selling medtech companies.