JETZT BEWERBEN Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a
Medical Device Clinical Safety Scientist
Background Portfolio Clinical Safety provide safety science and vigilance to support to molecules and medical devices across the Roche portfolio. As a group, they are responsible for all aspects of safety science and vigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable / activity.
Tasks & Responsibilities
Provide expert oversight and leadership for all clinical safety and vigilance activities for Class II and / or III Medical Devices (MD), ensuring compliance with global regulations and internal standards throughout the product lifecycle.
Manage and execute the MD vigilance process, including the intake, processing, assessment, and reporting of adverse events, ensuring timely and compliant submissions to regulatory authorities.
Review of core Medical Device study documentation to ensure robust inclusion of safety-related content. This includes, but is not limited to, the Clinical Investigation Plan (CIP / Protocol) and the Investigator’s Brochure (IB).
Develop and maintain the Reference Safety Information (RSI) for clinical investigations, ensuring its accuracy, proper dissemination, and timely updates based on emerging safety data.
Conduct and / or contribute significantly to Medical Device benefit-risk assessments, providing expert interpretation of clinical safety data to inform regulatory and business decisions.
Ensure the practical application and integration of MD risk management principles within clinical safety processes, aligning activities with the requirements of ISO 14971 (Medical devices – Application of risk management to medical devices).
Serve as the subject matter expert for all safety-related activities within MD clinical investigations.
Maintain an expert-level understanding and ability to practically apply the principles of ISO 14155 : 2020 (Clinical investigation of medical devices for human subjects – Good clinical practice) to the design, conduct, monitoring, recording, and reporting of clinical investigations, specifically concerning safety reporting and subject protection.
Provide guidance to clinical teams, investigators, and site staff on clinical investigation safety requirements, particularly those outlined in ISO 14155.
Bachelor, Masters or PhD within the scientific fields
Min. 3 years relevant Healthcare, Scientific or biomedical research background in clinical safety - with the use of MDs and / or combination products in the pharmaceutical / biotech or MD industry
Strong understanding of the biomedical technical aspects of MDs
Working knowledge of relevant MD regulations and industry standards
MD clinical investigations expertise : significant expertise and hands‑on experience in safety activities related to (Class II and / or III) MD clinical investigations, evidenced by practical experience in roles with safety responsibilities in MD clinical investigations
Expert‑level understanding and practical ability to apply ISO 14155 : 2020, and demonstrated strong ability to apply the standard in practice across all phases of MD clinical investigations
Experience developing and providing safety input for core MD clinical investigation documents, including the Clinical Investigation Plan (CIP / Protocol), Investigator’s Brochure (IB), and Reference Safety Information (RSI), with demonstrated ability independently and strategically to lead the development of these deliverables for MD clinical investigations
Risk Management : Demonstrable experience with MD benefit‑risk assessment and the practical application of MD risk management per ISO 14971
Experience with combination products (drug / MD)
Experience in Medical Device clinical safety and vigilance
Excellent communicators, leadership, team player
Nice to Have
Background in drug safety (pharmacovigilance) is an additional asset
What you will be offered
An opportunity to work in one of the world's most important pharmaceutical companies
Modern campus with plenty of green spaces and meeting areas
Central location in Basel
Varied job profile
Further training opportunities through temptraining
Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Diana Afonso.
Basel-Stadt Solothurn Aargau Safety Scientist MD Regulations Biomedical Investigations
#J-18808-Ljbffr