Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead quality and regulatory strategy for innovative medical devices, ensuring compliance and operational excellence.
- Company: Join a pioneering company at the forefront of medical technology.
- Benefits: Competitive salary, leadership opportunities, and a culture of empowerment and collaboration.
- Other info: Dynamic role with opportunities for growth in a fast-paced environment.
- Why this job: Make a real impact in healthcare by driving innovation and quality in medical devices.
- Qualifications: 8+ years in Regulatory Affairs and Quality, with strong knowledge of medical device regulations.
The predicted salary is between 43200 - 72000 £ per year.
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.
- Growth mindset and courageously authentic approach aligned with the company's values of empowerment, accountability, and inclusion.
Director of Quality and Regulatory Affairs in London employer: hays-gcj-v4-pd-online
Contact Detail:
hays-gcj-v4-pd-online Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Quality and Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Director of Quality & Regulatory Affairs role. You never know who might have the inside scoop on an opportunity or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on the latest regulations and trends in the medical device sector. Show that you’re not just knowledgeable but also passionate about driving quality and compliance. We want to see you shine as a thought leader!
✨Tip Number 3
Don’t forget to showcase your leadership skills! Be ready to discuss how you've developed high-performing teams and fostered collaboration in previous roles. We love hearing about your experiences in empowering others and driving operational excellence.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for candidates who align with our values of empowerment, accountability, and inclusion. Let’s get you in the door!
We think you need these skills to ace Director of Quality and Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Director of Quality and Regulatory Affairs. Highlight your experience in regulatory affairs and quality within the medical device industry, especially focusing on UKCA marking and global registrations.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of how you've led teams, managed budgets, and navigated complex regulatory environments. Make it personal and engaging!
Showcase Your Leadership Skills: Since this is a senior leadership role, emphasise your experience in leading high-performing teams. Talk about how you've fostered collaboration and continuous improvement in your previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
How to prepare for a job interview at hays-gcj-v4-pd-online
✨Know Your Regulations Inside Out
Make sure you brush up on the latest regulations like ISO 13485, MDSAP, and UKCA marking. Being able to discuss these confidently will show that you're not just familiar with the requirements but also understand how they impact the business and innovation.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams in the past, especially in high-pressure situations. Highlight your ability to foster collaboration and continuous improvement, as this role requires a strong leader who can empower their team and drive operational excellence.
✨Demonstrate Cross-Functional Collaboration
Think of specific instances where you've partnered with R&D, clinical teams, or commercial squads. Be ready to explain how you provided regulatory expertise and quality oversight during new product development, as this will be crucial for the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to simplify complexity. Prepare to discuss how you would handle regulatory changes or compliance risks, showcasing your strategic thinking and adaptability in a fast-changing environment.