Regulatory Affairs Manager in Bishopsgate, Greater London

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