Quality Assurance Regulatory Affairs Manager

Bluetree Recruits; Cambridge; Hybride; GBP 90 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory leadership

FDA expertise

QMS management

International regulation

Formation

RA/QA qualifications

Description du poste

Senior Regulatory Affairs & Quality Manager - Cambridge, Cambridgeshire

Are you the person regulators, notified bodies and leadership teams turn to when the answer really matters? Bluetree are working with an innovative cardiology medical device company in Cambridge that's taking its technology into the US and onto the world stage. They need a senior regulatory and quality leader to set the direction and deliver it.

This isn't a role for someone who only manages. They want an expert who knows the FDA inside out, can interpret complex regulation with confidence, and gets stuck into the detail. This is a full time permanent hybrid role.

What you'll be doing

• Leading regulatory strategy for the US first, then the UK, EU and new markets including the Middle East
• Owning FDA, CE and UKCA submissions, from Class I self-certified to Class II/III devices
• Driving a compliant, audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971)
• Advising the senior team on regulation, quality, clinical governance and risk
• Working directly with the FDA, MHRA and notified bodies, including BSI
• Deciding when to bring in consultants, and making sure the business gets value from them

What you'll bring

• 15+ years in Medical Device Regulatory Affairs and Quality, including time at senior level
• Strong, hands‑on experience of FDA processes and submissions
• Solid CE marking experience under EU MDR and UK MDR
• Experience of international regulation across multiple markets
• Formal training and qualifications in RA/QA. Cardiology device experience would be a real bonus

Why this role?

You’ll be the trusted regulatory voice in a growing company. You’ll have real influence on how it reaches patients worldwide, with hybrid working of 2 days a week in Cambridge.

We offer equal opportunities to all candidates regardless of race, religion, gender, sexuality, disability, age and other protected status as required by applicable law.

We can only consider applications from candidates who are eligible to work in the UK.