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

Job Summary

This role at quartett GmbH, a family-owned biotechnology company specializing in cancer diagnostics, involves supporting the creation, maintenance, and updating of technical documentation in accordance with IVDR (In Vitro Diagnostic Regulation). The specialist will assist in implementing IVDR requirements for in-vitro diagnostics, communicate with notified bodies and authorities, and monitor regulatory changes. They will collaborate closely with colleagues in development, quality assurance, and production, and provide support during internal and external audits. This position offers an opportunity to contribute to a growing company dedicated to improving tumor diagnostics, working within a motivated team with flexible hours in the Potsdam Science Park.