Senior Clinical Development Lead / Medical Safety Physician

About the role

Roche is seeking a Senior Clinical Development Lead and Medical Safety Physician to ensure the safety and integrity of Roche‑branded products. Based in Vienna, you will work across the mySugr, Accu‑Chek, navify and other Roche portfolios, providing medical authority throughout the product safety lifecycle.

Key responsibilities

• Conduct comprehensive medical risk analyses, including Health Hazard Evaluations, Medical Risk/Safety Assessments and Safety Board meetings.
• Handle regulatory inquiries from international authorities regarding adverse event reporting and product recalls.
• Prepare internal and external medical safety evaluations for diagnostics products (Core Lab, Molecular Lab, Near Patient Care, Diabetes Care).
• Lead internal training to optimise the interface between Customer Issue Resolution and Medical Safety.
• Represent Medical Safety in internal Safety Board processes and maintain procedural documentation, SOPs and guidelines.

Required profile

• Medical degree (MD or equivalent) with hands‑on clinical experience; medical licence preferred.
• Background in clinical practice combined with expertise in applied laboratory medicine and diagnostic methodologies.
• Strong collaborative, analytical and decision‑making abilities.

Required skills

• Familiarity with EU IVDR (2017/746) and US IVD regulations.
• Knowledge of medical device regulations (EU MDR 2017/745) and related software standards.
• Understanding of risk‑management standards EN ISO 14971 and TR 24971.