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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: 01.01.2026 or 01.02.2026
• Latest Possible Start: 01.03.2026
• 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)

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