At a Glance
- Tasks: Lead regulatory strategy for FDA submissions and ensure compliance for medical devices.
- Company: Innovative, venture-backed medical device company in London with a dynamic culture.
- Benefits: Competitive salary, equity options, and opportunities for travel.
- Other info: Join a fast-paced team and grow the regulatory function over time.
- Why this job: Make a real impact during a crucial phase of the company's growth.
- Qualifications: 6-7+ years in regulatory affairs with hands-on FDA submission experience.
The predicted salary is between 63000 - 77000 £ per year.
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 includes:
- Leading the company’s 510(k) through FDA review and clearance, including predicate strategy, substantial equivalence and Additional Information responses.
- Acting as the primary FDA contact and leading Pre-Submission meetings.
- Coordinating test evidence across engineering, CROs and test houses (electrical safety, software, biocompatibility, bench, sterilisation).
- Building US post-market processes: registration and listing, UDI/GUDID, MDR, complaints and recalls.
- Assessing design and manufacturing changes for 510(k) impact.
- Shaping the UK and EU MDR strategy as the business grows.
- Growing 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.
Regulatory Affairs Manager in London employer: GxPeople Global
As a leading healthcare technology and diagnostics company, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to make a meaningful impact in the medical field. Our commitment to professional development ensures that you will have ample opportunities for growth while working on cutting-edge diagnostic devices in a supportive environment located in the UK. Join us to be part of a mission-driven team dedicated to improving patient outcomes through advanced technology.
