Senior Clinical Development Lead / Senior Medical Safety Physician (m/f/d)
Core
Uphold safety and integrity of Roche-branded diagnostic products by overseeing the full product safety lifecycle from premarket risk evaluations to postmarket complaint resolution.
Role type
Senior Medical Safety Physician / Clinical Development Lead
Builds
Medical Risk Assessments, Health Hazard Evaluations, Risk Enablers, and criteria for Potential Reportable or Safety Issues
Domain
Medical Diagnostics (Laboratory Medicine, Molecular Lab, Near Patient Care, Diabetes Care)
Required skills
Medical degree (MD or equivalent), hands-on clinical experience, regulatory standards knowledge (EU IVDR, US IVD), risk management standards (ISO 14971, TR 24971), expert evaluation capabilities, process optimization, documentation compliance
Preferred skills
Medical license or equivalent registration, expertise in applied laboratory medicine and diagnostic methodologies, experience with medical devices and software (EU MDR)
Technologies
EU IVDR, US IVD regulations, EU MDR, ISO 14971, TR 24971
Responsibilities
Conduct comprehensive medical risk analyses and safety board meetings, process regulatory inquiries regarding adverse events and recalls, prepare internal and external medical safety evaluations, plan and conduct training sessions for operational optimization, represent Medical Safety in the Safety Board process, maintain and update procedural documents and SOPs
Seniority
Senior, hands-on IC
