Overview In this role, you lead medical safety and risk management for Roche-branded products, overseeing the full safety lifecycle from premarket to postmarket. You act as the medical authority across R&D;, quality, and vigilance, informing Safety Board decisions and ensuring regulatory alignment. You'll translate clinical insights into safety evaluations and help optimize interfaces between customer issue resolution and medical safety.
This position offers high-impact work in a global, collaborative environment aimed at safer, smarter healthcare solutions. Compensaciones / Incentivos competitive compensation packages equal opportunity employer family-friendly career paths flexible working arrangements sustainability-focused culture healthy lifestyle benefits Responsabilidades Perform comprehensive medical risk analyses (Health Hazard Evaluations, Medical Risk/Safety Assessments)



and contribute to Safety Board discussions Handle regulatory inquiries related to adverse event reporting and product recalls across international authorities Prepare internal and external medical safety evaluations and expert opinions for Diagnostics across Core Lab, Molecular Lab, Near Patient Care, and Diabetes Care Plan and conduct internal trainings to optimize CIR and Medical Safety workflows Represent Medical Safety in Safety Board processes and provide medical assessments to inform board decisions Maintain and update procedural documents, guidelines, and SOPs/GSPs within scope Requisitos principales MD or equivalent; medical licence preferred hands-on clinical experience familiarity with EU IVDR (2017/746) and US IVD regulations; experience with medical devices/software preferred (EU MDR, 2017/745) strong knowledge of EN ISO 14971 and TR 24971 interpersonal, negotiation, analytical, adaptable, decisive fluent in English collaborative mindset effective negotiation analytical thinking EU IVDR and US IVD regulatory knowledge medical device and medical device software awareness risk man

📌 Senior clinical development lead (San Cugat del Vallés)
🏢 Jobrapido
📍 San Cugat del Vallés