Regulatory Affairs Manager Medical Devices
London Hybrid Permanent I Salary Dependant on Experience
I m working exclusively with an innovative, venture-backed medical device company in London that is gearing up for a FDA 510(k) submission. They re hiring a Regulatory Affairs Manager, who will own regulatory strategy from day one.
The role
- Lead the company s 510(k) through FDA review and clearance, including predicate strategy, substantial equivalence and Additional Information responses
- Act as the primary FDA contact and lead Pre-Submission meetings
- Coordinate test evidence across engineering, CROs and test houses (electrical safety, software, biocompatibility, bench, sterilisation)
- Build US post-market processes: registration and listing, UDI/GUDID, MDR, complaints and recalls
- Assess design and manufacturing changes for 510(k) impact
- Shape the UK and EU MDR strategy as the business grows
- Grow the regulatory function over time, including budgets, consultants and, in time, a team
What you ll bring
- 6-7+ years regulatory affairs experience in medical devices
- Hands-on authorship of at least one successful FDA 510(k)
- Direct FDA interaction experience, such as Pre-Subs and AI responses
- Working knowledge of 21 CFR 820 (QMSR), ISO 13485 and ISO 14971
- Experience with active or electromechanical Class II/III devices (IEC 60601, IEC 62304) is a strong plus
- EU MDR and RAC are a bonus
- Comfortable in a small, fast-moving team where you ll be hands-on
- Right to work in the UK (sponsorship is not available)
Why it s worth a look
- You ll own regulatory strategy at the most important point in the company s life: FDA submission and US launch
- A direct line to the CEO, with real influence on the business
- Equity through share options
- Occasional US and European travel