Medical Device Clinical Safety Scientist (m/f/d) (LSW) - BS

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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
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Latest Possible Start:
01.03.2026
•
Duration:
6 months initially; extension possible (e.g., additional 6 months)
•
Location:
Basel
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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
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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.
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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
.
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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
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Bachelor's, Master's or PhD in a scientific or medical discipline.
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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.
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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?
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Leroy Omokhuale