Our client who is developing an advanced and innovative wound dressing platform (Advanced Tissue Repair Platform) to substantially, will improve the clinical outcome for patients with Chronic and Complex Wounds whilst maintaining simplicity for care providers. Our Client is on a mission to improve the current standard of care to reduce the physical and psychological impact of poor wound healing on patients that suffer from these wounds.
Our client prides themselves on being a pragmatic, a lean start-up that’s driven to deliver world-changing technologies at pace and responding to challenges flexibly and rapidly. The Quality Assurance and Regulatory Affairs Director will be responsible for developing, implementing, and maintaining quality and regulatory systems in compliance with FDA, ISO, and other global regulatory standards. This role requires deep experience in medical device development — particularly durable medical equipment — combined with working knowledge of regenerative therapies and their evolving regulatory pathways.
Develop and maintain a robust Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable standards.
⬢ Oversee design control, risk management (ISO 14971), and product lifecycle quality from R&D to post-market surveillance.
⬢ Establish and monitor key quality metrics and provide executive-level reporting.
⬢ Ensure supplier and contract manufacturer compliance through audits, qualification, and continuous monitoring.
⬢ Define and lead global regulatory strategy for the company’s medical device and regenerative medicine products.
⬢ Prepare and submit CE mark Technical Files, FDA submissions (510(k), IDE, PMA) and other international regulatory dossiers.
⬢ Serve as the primary regulatory liaison with notified bodies, FDA and other global regulatory authorities.
⬢ Monitor changes in the regulatory landscape (e.g., FDA, EMA, MDR) and advise leadership on compliance risks and opportunities.
⬢ Support clinical and preclinical study design from a regulatory perspective
A bachelor’s degree in engineering, life sciences, or a related field.
⬢ Minimum of 8-10 years of experience in QA/RA roles within the medical device industry.
⬢ Proven experience with durable medical equipment (DME) and familiarity with regenerative medicine (e.g., Demonstrated strong leadership and team-building abilities.
⬢ A chance to shape the quality and regulatory foundations of a company disrupting the wound care industry.
⬢ Competitive salary and equity package.
⬢ Flexible work environment and schedule.
⬢ Opportunity for significant professional growth and leadership development.