Job Description
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:
1. Maintain and continuously improve the ISO 13485-compliant QMS, driving successful certification.
2. Prepare and implement QMS policies, procedures, and documentation.
3. Lead internal and supplier audits, management reviews, and CAPA/continuous improvement initiatives.
4. Manage technical documentation and DHFs in compliance with EU MDR and UK MDR.
5. Oversee regulatory and quality compliance during clinical investigations and p...