Regulatory Affairs Professional Medical Devices and IVD - Hybrid | Regulatory Affairs Professional Medical Devices (x|w|m) – Hybrid

Job Summary

This role involves ensuring regulatory compliance for Medical Devices (MDs) and In Vitro Diagnostic Devices (IVDs) within Sartorius Stedim Biotech GmbH in Göttingen. The professional will be responsible for preparing and executing clinical and performance data documentation, as well as Post-Market Surveillance (PMS) documents for both MDs and IVDs. Key responsibilities include scientific writing for technical documentation, conducting market research, performing risk assessments, and implementing corrective actions for incidents. The role requires advising internal stakeholders on regulatory changes, communicating with regulatory authorities, and developing and implementing new processes to meet evolving regulatory requirements. Candidates must possess a Master's degree in a relevant scientific field and bring initial experience in Regulatory Affairs for medical devices and/or IVDs. This is a full-time, fixed-term contract until May 31, 2027, with hybrid work options.