Regulatory Affairs Specialist (IVDR Focus) | Biologe (m/w/d)

Job Summary

This role as a Regulatory Affairs Specialist, focusing on the In-vitro Diagnostic Regulation (IVDR), is crucial for a second-generation family-owned biotechnology company specializing in cancer diagnostics. The core responsibilities involve supporting the creation, maintenance, and updating of technical documentation to ensure full compliance with IVDR requirements for the company's IVD products. Day-to-day tasks include monitoring regulatory changes, researching new requirements, assisting with their internal implementation, and supporting communication with notified bodies and regulatory authorities. You will collaborate closely with colleagues in Development, Quality Assurance, and Production, and assist with internal and external audits. The ideal candidate possesses a scientific, medical, or technical degree and brings initial experience in Regulatory Affairs or Quality Assurance, ideally within the IVD or medical device sector. This position offers a secure, full-time role within a growing, motivated team, providing exciting and varied tasks with scope for personal contribution and flexible working hours.