QARA Director

Job DescriptionOur client is a dynamic and innovative start-up developing an advanced wound dressing platform designed to significantly improve outcomes for patients with chronic and complex wounds, with a mission to enhance the standard of care while maintaining simplicity for healthcare providers. As a lean and pragmatic team, they are committed to delivering transformative technologies with agility and purpose.Job SummaryThe Quality Assurance and Regulatory Affairs Director (stand-alone position) 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 whilst being extremely hands on. Key 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 companys 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.Ideal Candidate Profile A bachelors 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.Whats on Offer A chance to shape the regulatory and quality foundations of a company disrupting the wound care industry. Competitive salary and equity package. Flexible work environment and schedule.

Created: 2025-06-17