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.