Medical Device Clinical Safety Scientist | Medical Device Clinical Safety Scientist (m/f/d) (LSW) - BS

Job Summary

The Clinical Safety Scientist will join the Portfolio Clinical Safety (PCS) organization, providing essential scientific safety expertise and vigilance support specifically for Class II and Class III medical devices during clinical investigations. This role is crucial for ensuring regulatory compliance and patient safety across the product lifecycle. Day-to-day responsibilities include leading clinical safety and vigilance activities, overseeing the adverse event reporting process (intake, processing, assessment, and timely submission), and acting as the subject matter expert for safety aspects in clinical investigations. A key focus involves preparing and reviewing safety content for critical documentation such as the Clinical Investigation Plan (CIP), Investigator’s Brochure (IB), and Reference Safety Information (RSI). The ideal candidate is an independent, self-driven professional with expert knowledge of ISO 14155:2020 and ISO 14971 principles, ready to contribute expert interpretation of safety data to benefit-risk assessments within cross-functional, multicultural teams.