QARA / Quality Assurance and Regulatory Affairs Director

Our client is developing an advanced and innovative wound dressing platform (Advanced Tissue Repair Platform) to substantially 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. This role will have high visibility within the company, providing a chance to shine and be rewarded. Our client prides themselves on being a pragmatic, lean start-up that’s driven to deliver world-changing technologies at pace and responding to challenges flexibly and rapidly.

JOB SUMMARY

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. The ideal candidate will thrive in a fast-paced startup environment and bring strategic leadership, cross-functional collaboration, and executional excellence.

ESSENTIAL RESPONSIBILITIES

• Develop and maintain a robust Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable standards.
• Lead internal and external audits, CAPA processes, non-conformance investigations, and change control.
• 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.

THE IDEAL CANDIDATE WILL HAVE

• 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., synthetic biodegradable polymers, HCT/Ps, combination products).
• Direct experience preparing and submitting successful EU MDD and/or MDR and FDA PMAs.
• Deep understanding of ISO 13485, FDA QSR, MDSAP, EU MDR, and related standards.
• A startup mentality: self-starter, hands-on, resourceful, and adaptable.
• Demonstrated strong leadership and team-building abilities.
• Excellent communication and cross-functional collaboration skills.
• A strategic thinker mindset with attention to detail and a proactive problem-solving approach.

IN RETURN OUR CLIENT OFFERS

• 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.