Senior Quality & Regulatory Manager - SaMD (Hybrid UK)

Heim is recruiting its first Quality & Regulatory Affairs Manager to own safety, compliance and trust for Heim Software and upcoming UKCA classifications. You will lead the ISO 13485 quality management system, guide MDR and UK regulatory routes, and act as Data Protection Officer, bringing governance in-house from external support.

You will collaborate across Product and Engineering to ensure post-market evidence, risk management and regulatory documents keep pace with fast-moving AI-enabled