Regulatory Affairs Manager

GxPeople Global; City Of London; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

GXPeople Global Ltd. in London is seeking a Regulatory Affairs Manager for medical devices who will own regulatory strategy from day one, including US FDA submissions and EU MDR planning.

The role leads the FDA 510(k) process, coordinates engineering CROs and test houses, and builds post-market processes such as registration, UDI/GUDID and recalls. You will influence growth and work directly with the CEO in a fast-moving team.

Qualifications

• 6-7+ years regulatory affairs experience in medical devices.
• Hands-on authorship of at least one successful FDA 510(k).
• Direct FDA interaction experience (e.g., Pre-Subs).
• Knowledge of 21 CFR 820 (QMSR), ISO 13485 and ISO 14971.
• Experience with active or electromechanical Class II/III devices (IEC 60601, IEC 62304).
• EU MDR knowledge and RAC is a bonus.
• Comfortable in a small, fast-moving team and hands-on.

Responsibilities

• Lead the 510(k) through FDA review and clearance, including predicate strategy and responses.
• Act as the primary FDA contact and lead Pre-Submission meetings.
• Coordinate test evidence across engineering, CROs and test houses.
• Build US post-market processes: registration/listing, UDI/GUDID, MDR, complaints/recalls.
• Assess design/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 and team.

Skills

FDA communications

Regulatory strategy

QMS/ISO knowledge

Job description

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