Descripción del trabajo

Experteer 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 Ru0026amp;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.
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
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
Requisitos principales

competitive compensation packages
equal opportunity employer
family-friendly career paths
flexible working arrangements
sustainability-focused culture
healthy lifestyle benefits

📌 Senior Clinical Development Lead (Madrid)
🏢 Roche
📍 Madrid