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 company’s 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.