Medical Device Clinical Safety Scientist

Vor 2 Tagen

Basel, Basel-Stadt, Schweiz Manpower Switzerland Vollzeit

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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

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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