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 integral, collaborative environment aimed at safer, smarter healthcare solutions.

Compensaciones / Beneficioscompetitive compensation packagesequal opportunity employerfamily-friendly career pathsflexible working arrangementssustainability-focused culturehealthy lifestyle benefits
ResponsabilidadesPerform comprehensive medical risk analyses (Health Hazard Evaluations, Medical Risk/Safety Assessments)



and contribute to Safety Board discussionsHandle regulatory inquiries related to adverse event reporting and product recalls across international authoritiesPrepare internal and external medical safety evaluations and expert opinions for Diagnostics across Core Lab, Molecular Lab, Near Patient Care, and Diabetes CarePlan and conduct internal trainings to optimize CIR and Medical Safety workflowsRepresent Medical Safety in Safety Board processes and provide medical assessments to inform board decisionsMaintain and update procedural documents, guidelines, and SOPs/GSPs within scope
Requisitos principalesMD or equivalent; medical licence preferredhands-on clinical experiencefamiliarity 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 24971interpersonal, negotiation, analytical, adaptable, decisivefluent in Englishcollaborative mindseteffective negotiationanalytical thinkingEU IVDR and US IVD regulatory knowledgemedical device and medical device software awarenessrisk management standards EN IS

📌 Senior Clinical Development Lead (San Cugat del Vallés)
🏢 Jobrapido
📍 San Cugat del Vallés