Medical Device Clinical Safety Scientist

**​** **MANPOWER AG – Your Career, Our Focus** Become part of our network and take advantage of countless opportunities ManpowerGroup is the leading global company for staffing solutions. With our three brands – Manpower, Experis, and Talent Solutions – we assist companies across various industries with their recruitment needs. For 75 years, we've operated in over 75 countries, and throughout Switzerland, we support our clients in successfully completing their tasks and projects. **We are looking for a Medical Device Clinical Safety Scientist (m/f/d) (LSW) - BS****​** ### **Overview / Background** The Portfolio Clinical Safety (PCS) organisation provides scientific safety expertise and vigilance support for medical devices and molecules across the entire Roche portfolio. The team oversees all safety-related responsibilities, with accountability shared between PCS leadership and specialised Safety Strategy Leaders (SSLs), depending on the deliverable. ### **Ideal Candidate Profile** We are seeking a professional with strong expertise in the clinical safety of Class II and/or Class III medical devices, particularly in the context of clinical investigations. The role requires an independent, self-driven individual who can work effectively within cross-functional and multicultural teams. The primary focus of this position is to support medical device clinical investigations by preparing and reviewing safety-related content in key documentation, such as the Clinical Investigation Plan (CIP/Protocol), the Investigator's Brochure (IB), and the Reference Safety Information (RSI).
--- **General Information** **Start Date:** or **Latest Possible Start:** **Duration:** 6 months initially; extension possible (e.g., additional 6 months) - **Location:** Basel - **Workload:** 100% - **Home Office:** Yes - **Travel:** Not expected - **Team Size:** PCS safety team approx. 6; cross-functional project teams 5–10 members - **Hiring Manager:** Simone Melega - **Department:** Portfolio Clinical Safety (PCS), PDS - **Working Hours:** Standard --- **Tasks & Responsibilities** Provide expert leadership for all clinical safety and vigilance activities related to Class II/III medical devices throughout the product lifecycle. - Oversee the full medical device vigilance process, including intake, processing, assessment and timely submission of adverse events to regulatory authorities. - Review key clinical investigation documents to ensure high-quality inclusion of safety-related content (e.g., CIP/Protocol, Investigator's Brochure). - Develop, maintain and update the Reference Safety Information (RSI) based on new and emerging safety data. - Lead or significantly contribute to benefit-risk assessments, offering expert interpretation of clinical safety data to guide regulatory and business decisions. - Ensure alignment with medical device risk management principles in accordance with **ISO 14971**. - Act as the subject matter expert for all safety-related aspects of medical device clinical investigations. - Apply the principles of **ISO 14155:2020** to all stages of clinical investigations, including design, conduct, monitoring, documentation and safety reporting. - Provide guidance to study teams, investigators and site personnel regarding safety requirements in medical device clinical investigations.
--- **Must Haves** Bachelor's, Master's or PhD in a scientific or medical discipline. - Minimum 3 years of relevant experience in healthcare, scientific or biomedical research with exposure to clinical safety and the use of medical devices or combination products. - Strong understanding of the technical and biomedical aspects of medical devices. - Solid working knowledge of relevant medical device regulations and industry standards. - Demonstrated hands-on experience in safety activities for Class II and/or III medical device clinical investigations. - **Expert-level understanding of ISO 14155:2020**, with proven practical application across all phases of clinical investigations. - Experience preparing safety input for CIP/Protocol, IB and RSI, including the ability to independently lead the development of these deliverables. - Strong background in benefit-risk assessment and medical device risk management aligned with **ISO 14971**. - Experience with drug/device combination products. - Excellent communication, leadership and teamwork skills.
--- **Nice to Have** Background in drug safety (pharmacovigilance) **​** **Dissatisfied, unchallenged, or eager to discover something new?** What are you waiting for? Apply now, unlock your potential, and aim for greater satisfaction in your career. I'm here to support you with my expertise and guide you through the entire application process. I look forward to meeting you and am excited to hear your story **MANPOWER AG – Together, we shape your future**

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