Senior RA & QA Leader - Medical Devices, Hybrid UK

Bluetree Recruits; Cambridge; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Bluetree Recruits is seeking a Senior Regulatory Affairs & Quality Manager in Cambridge to shape regulatory strategy for the US first and expand globally. You will own FDA, CE and UKCA submissions and lead a robust QMS, partnering with leadership to manage risk and compliance in a global market.

The role offers hybrid working with two days per week in Cambridge, and the ideal candidate has extensive FDA experience, EU MDR/UK MDR expertise, and a track record across multiple regions.

Qualifications

• 15+ years in Medical Device Regulatory Affairs and Quality, including senior work.
• Strong hands-on FDA process experience and submissions.
• CE marking experience under EU MDR and UK MDR.
• Experience regulating multiple international markets.
• Cardiology device experience is a bonus.

Responsibilities

• Lead regulatory strategy for US first, then UK/EU and new markets.
• Own FDA, CE and UKCA submissions for devices across classes.
• Drive a compliant, audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971).
• Advise senior management on regulation, quality, clinical governance and risk.
• Collaborate with FDA, MHRA and notified bodies (e.g., BSI).
• Decide when to engage consultants and maximise value.

Skills

Regulatory leadership

FDA expertise

QMS management

International regulation

Education

RA/QA qualifications

Job description

Bluetree Recruits is seeking a Senior Regulatory Affairs & Quality Manager in Cambridge to shape regulatory strategy for the US first and expand globally. You will own FDA, CE and UKCA submissions and lead a robust QMS, partnering with leadership to manage risk and compliance in a global market.

The role offers hybrid working with two days per week in Cambridge, and the ideal candidate has extensive FDA experience, EU MDR/UK MDR expertise, and a track record across multiple regions.