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 / Beneficios
- competitive compensation packages
- equal opportunity employer
- family-friendly career paths
- versátil 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 devi

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