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.
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.
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.
~ 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.
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!