Regulatory Affairs Manager

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