QA/RA Director

Job Summary:

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