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 ..... full job details .....