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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:
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