The RoleI’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 ensuringpliance, enabling innovation, and driving operational excellence across a diverse portfolio of medical devices from physical and digital technologies to in‑vitro diagnostics.You will:
1. Set and execute QA/RA strategy for UKCA marking, global registrations, and lifecycle maintenance, ensuring alignment with evolving regulations and business priorities.
2. Lead and develop a high‑performing team, fostering empowerment, collaboration, and continuous capability building.
3. Partner across the organisation, from R&D and clinical teams tomercial squads to provide regulatory expertise and quality oversight for new product development and market access.
4. Represent thepany externally, engaging with trade associations (ABHI, MedTech, etc.), monitoring regulatory changes, and influencing industry standards.
5. Own the Quality Management System (QMS), ensuringpliance with ISO 13485, MDSAP, EU MDR/IVDR, UKCA, and FDA QSR; maintain audit readiness and drive continuous improvement.
6. Support MHRA interactions, external audits, and regulatory filings; minimisepliance risks and enable timely approvals.
7. Champion a culture of quality and agility, balancing regulatory rigour with innovation and speed to market.
Key Responsibilities
8. Direct global and UK regulatory operations for product registrations, renewals, and change notifications.
9. Provide strategic input into global registration plans, optimising cost, timelines, andpliance.
10. Monitor regulatory intelligence and assess impact of new UK regulations (including sustainability/environmental requirements).
11. Oversee design control, risk management, post‑market surveillance, CAPA, and supplier quality.
12. Prepare and manage QA/RA budgets; track performance metrics and report to senior leadership.
13. Deliver training and coaching on medical device regulations and quality standards.
What We’re Looking For
14. 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.
15. Strong knowledge of ISO 13485, MDSAP, EU MDR/IVDR, UKCA, FDA QSR, and design control principles.
16. Experience in people leadership, budget management, and cross‑functional collaboration.
17. Excellentmunication, negotiation, and problem‑solving skills; able to simplifyplexity and influence decisions.
18. Degree in a scientific or technical discipline (or equivalent).
19. Resilient, adaptable, andfortable operating in a fast‑changing environment.
Growth mindset and courageously authentic approach aligned with thepanies values of empowerment, accountability, and inclusion #4755056 - Mark Allen