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Position: Quality & Regulatory Affairs (QARA) Professional Location: Cambridge (On-site) | Full-time or Part-time (flexible depending on experience) Overview: An innovative MedTech start-up is seeking an experienced Quality and Regulatory Affairs professional to lead and maintain compliance across ISO 13485 , UK MDR , and EU MDR frameworks. The company is developing a novel sampling medical device to support early detection and management of cancer. This is an opportunity to play a key role in a small, collaborative team, shaping the companys quality and regulatory foundations while driving ISO certification and product readiness. Key Responsibilities: Maintain and continuously improve the ISO 13485-compliant QMS , driving successful certification. Prepare and implement QMS policies, procedures, and documentation . Lead internal and supplier audits , management reviews, and CAPA/continuous improvement initiatives. Manage technical documentation and DHFs in compliance with EU MDR and UK MDR. Oversee regulatory and quality compliance during clinical investigations and post-market activities. Act as the Person Responsible for Regulatory Compliance (PRRC) . Monitor regulatory changes and advise leadership on compliance implications. Serve as the main contact for Notified Bodies, auditors, and competent authorities . Support training and awareness of QARA processes across the organisation. Requirements: Proven experience with medical devices (ideally Class I) under UK and EU regulatory frameworks . Strong working knowledge of ISO 13485 , including implementation and audit experience. Familiarity with ISO 14971, ISO 14155, ISO 10993, and IEC 62366-1 . Experience managing clinical investigation documentation . Confident managing a QMS independently within a fast-paced, start-up environment . Excellent organisational, communication, and problem-solving skills. Why Join: Work at the forefront of health innovation and contribute to meaningful diagnostic advancements. Opportunity to influence QARA strategy in a high-growth environment. Competitive package, professional growth, and involvement across multiple clinical programmes.55b20050-bc17-4e5d-bfce-3c406318dffc