Director of Quality and Regulatory Affairs
JOB_53625284755056Job type
ContractLocation
LondonWorking Pattern
Full-timeSpecialism
Regulatory AffairsIndustry
Healthcare & MedicalPay
Flexible DOE
Director of Quality and Regulatory Affairs - Medical Devices - London
The Role
I’m working with an incredibly innovative client to find a Director of Quality & Regulatory Affairs to lead their UK Medical Device regulatory and quality strategy. This is a senior leadership role responsible for ensuring compliance, enabling innovation, and driving operational excellence across a diverse portfolio of medical devices from physical and digital technologies to in‑vitro diagnostics.
You will:
- Set and execute QA/RA strategy for UKCA marking, global registrations, and lifecycle maintenance, ensuring alignment with evolving regulations and business priorities.
- Lead and develop a high‑performing team, fostering empowerment, collaboration, and continuous capability building.
- Partner across the organisation, from R&D and clinical teams to commercial squads to provide regulatory expertise and quality oversight for new product development and market access.
- Represent the company externally, engaging with trade associations (ABHI, MedTech, etc.), monitoring regulatory changes, and influencing industry standards.
- Own the Quality Management System (QMS), ensuring compliance with ISO 13485, MDSAP, EU MDR/IVDR, UKCA, and FDA QSR; maintain audit readiness and drive continuous improvement.
- Support MHRA interactions, external audits, and regulatory filings; minimise compliance risks and enable timely approvals.
- Champion a culture of quality and agility, balancing regulatory rigour with innovation and speed to market.
Key Responsibilities
- Direct global and UK regulatory operations for product registrations, renewals, and change notifications.
- Provide strategic input into global registration plans, optimising cost, timelines, and compliance.
- Monitor regulatory intelligence and assess impact of new UK regulations (including sustainability/environmental requirements).
- Oversee design control, risk management, post‑market surveillance, CAPA, and supplier quality.
- Prepare and manage QA/RA budgets; track performance metrics and report to senior leadership.
- Deliver training and coaching on medical device regulations and quality standards.
What We’re Looking For
- 8+ years’ experience in Regulatory Affairs and Quality within the medical device industry (IVD or MD), with proven success in UKCA marking and global registrations.
- Strong knowledge of ISO 13485, MDSAP, EU MDR/IVDR, UKCA, FDA QSR, and design control principles.
- Experience in people leadership, budget management, and cross‑functional collaboration.
- Excellent communication, negotiation, and problem‑solving skills; able to simplify complexity and influence decisions.
- Degree in a scientific or technical discipline (or equivalent).
- Resilient, adaptable, and comfortable operating in a fast‑changing environment.
Director of Quality and Regulatory AffairsJOB_536252847550562025-12-122026-03-13
Talk to Mark Allen, the specialist consultant managing this position
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JOB_53625284755056