Regulatory Affairs Manager - In Vitro Diagnostics (IVD) | Biologe (m/w/d)
Zytomics
Job Summary
This role is for a dedicated Regulatory Affairs Manager specializing in In Vitro Diagnostics (IVD) at ZytoVision GmbH in Bremerhaven. The primary objective is to ensure the efficient and compliant market authorization of the company's clinical cancer diagnostics products across national and international markets. Day-to-day responsibilities include the creation and meticulous maintenance of technical documentation, including STED, for Germany, other EU states, and non-EU countries. The manager will coordinate complex international approval procedures, review and approve associated documentation, and continuously monitor evolving regulatory requirements. The position requires a Master's degree in Biology, Biotechnology, or a related technical field, foundational knowledge in Molecular Genetics and Immunohistochemistry, and strong analytical skills. This is an 18-month fixed-term contract with potential for extension, offering the opportunity to contribute significantly to global health in a dynamic, growing organization.
Required Skills
Education
Successful completion of a Master's or Diploma degree in Biology, Biotechnology, Medical Technology, or a comparable field.
Experience
- Professional experience in creating and maintaining technical documentation (STED)
- Professional experience coordinating national and international IVD product approval procedures
- Professional experience monitoring and implementing regulatory requirements
- Experience serving as a communication interface between Regulatory Affairs and other departments (R&D, QM, Sales)
Languages
Additional
- Fixed-term position for 18 months (with option for extension).