Medical Device Clinical Safety Scientist

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel, we are currently looking for a motivated and dedicatedMedical Device Clinical Safety Scientistfor a temporary assignment of 12 months. 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 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 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 Must Haves 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 Benefits Work with modern and up-to-date tools in an innovative work environment Experience a work culture that promotes diversity and inclusion and where all employees feel valued Benefit from financial support for your professional development plans Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere Take advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat Enjoy a selection of high-quality meals in modern staff restaurants As part of a sustainable mobility concept, on-site parking spaces are available to you, provided you meet the relevant qualifications Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days Are you interested? Donund#39;t hesitate and submit your complete application documents online today. We look forward to hearing from you Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen – unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.