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- Tasks: Lead quality assurance and regulatory affairs for innovative medical technologies.
- Company: Join a pioneering company focused on advanced wound care and regenerative therapies.
- Benefits: Enjoy flexible hybrid work, competitive salary, full benefits, and potential equity.
- Why this job: Shape the future of wound care in a mission-driven, collaborative team culture.
- Qualifications: 8+ years in QA/RA roles with experience in regulatory submissions and medical devices.
- Other info: Opportunity for long-term career growth and to define compliance strategy.
The predicted salary is between 43200 - 72000 £ per year.
A pioneering medical technology company focused on advanced wound care and regenerative therapies is seeking a Director of Quality Assurance & Regulatory Affairs to lead its global quality and compliance function.
Key Responsibilities:
- Lead internal and external audits, including CAPA systems, non-conformance investigations, and supplier qualification efforts.
- Develop and maintain company-wide quality metrics and executive-level reporting that drive continuous improvement and regulatory alignment.
- Provide regulatory leadership and input into clinical and preclinical programs, ensuring protocols meet global submission standards.
- Manage all regulatory submissions, including FDA 510(k), PMA, CE Mark Technical Files, and global market applications.
- Build and evolve a globally aligned Quality Management System (QMS) compliant with ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.
- Take ownership of design control, risk management (ISO 14971), and quality governance across R&D, manufacturing, and post-market surveillance.
- Act as the principal liaison for regulatory authorities and notified bodies, including oversight of inspections and compliance reviews.
- Monitor global regulatory developments (EU MDR, FDA, EMA) and ensure proactive strategy updates to maintain global compliance.
- Define and execute a company-wide regulatory strategy, encompassing medical devices, regenerative therapies, and combination products.
What We’re Looking For:
- A confident, experienced leader with the ability to operate both strategically and hands-on in a growing business.
- Proven experience in regulatory submissions and approvals (FDA PMA/510(k), EU MDR) and deep understanding of global pathways.
- A technical degree in Life Sciences, Quality, Engineering, or a relevant field.
- Background in durable medical equipment, implantable devices, or wound care technologies is strongly preferred.
- 8+ years in QA/RA leadership roles within the medical device sector.
- Familiarity with regenerative medicine and regulatory pathways for combination or hybrid products is a significant advantage.
- Demonstrated success working in startup or scale-up environments with adaptability and a solutions-driven mindset.
- Strong interpersonal skills with an ability to collaborate cross-functionally and communicate with influence.
Why Apply:
- A flexible hybrid working environment with meaningful autonomy and global exposure.
- A critical role shaping quality and regulatory foundations in a company driving next-gen wound care innovation.
- A collaborative, mission-led team culture that values continuous improvement and personal growth.
- Competitive base salary, full benefits, and potential equity participation.
- Long-term career progression and the chance to define quality and compliance strategy from the ground up.
If you're ready to grow your career in a growing Medical Device start up we’d love to hear from you!
Apply now or reach out for more details: lcattcamfield@barringtonjames.com +44 (0) 1293 776644
QA/RA Director employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA/RA Director
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in the medical device sector, especially ISO 13485 and FDA guidelines. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the QA/RA field, particularly those who have experience in startups or scale-ups. Engaging with industry peers can provide valuable insights and may even lead to referrals that could enhance your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led quality assurance initiatives or regulatory submissions in your previous roles. Highlighting your hands-on experience will showcase your ability to operate effectively in both strategic and operational capacities.
✨Tip Number 4
Research the company’s recent projects and innovations in wound care and regenerative therapies. Being knowledgeable about their work will allow you to tailor your discussions and show genuine interest in contributing to their mission.
We think you need these skills to ace QA/RA Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance and regulatory affairs, particularly in the medical device sector. Emphasise your leadership roles and any specific achievements related to regulatory submissions and compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the company's mission and how your background aligns with their needs. Mention your experience with FDA submissions, ISO standards, and any specific technologies relevant to wound care or regenerative therapies.
Highlight Key Skills: In your application, emphasise skills such as risk management, audit leadership, and cross-functional collaboration. Use specific examples to demonstrate how you've successfully navigated regulatory challenges in previous roles.
Showcase Continuous Improvement Initiatives: Discuss any initiatives you've led that resulted in improved quality metrics or compliance outcomes. This could include developing quality management systems or leading audits that enhanced operational efficiency.
How to prepare for a job interview at Barrington James
✨Understand the Regulatory Landscape
Familiarise yourself with the latest regulations and standards relevant to the medical device industry, such as FDA 510(k), PMA, and EU MDR. Being able to discuss these in detail will demonstrate your expertise and readiness for the role.
✨Showcase Your Leadership Experience
Prepare examples of how you've successfully led QA/RA teams in previous roles. Highlight specific instances where your leadership directly contributed to compliance improvements or successful regulatory submissions.
✨Emphasise Continuous Improvement
Be ready to discuss how you have implemented quality metrics and driven continuous improvement initiatives in past positions. This shows that you not only understand the importance of quality but also know how to instil a culture of excellence.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios, such as handling non-conformance investigations or managing audits. Practising these scenarios can help you articulate your thought process and decision-making skills effectively.
