Medical Device Clinical Safety Scientist

vor 14 Stunden

Basel, Basel-Stadt, Schweiz Actalent Vollzeit

Our client is seeking an experienced
Medical Device Clinical Safety Expert
to provide strategic safety oversight and vigilance for Class II and/or III medical devices throughout their lifecycle. This role focuses on supporting clinical investigations by delivering expert safety input into key documentation and processes. The ideal candidate will work independently while collaborating effectively within multifunctional and multicultural teams, demonstrating strong leadership and technical expertise in medical device safety.

Responsibilities

  • Lead and oversee all clinical safety and vigilance activities for Class II and/or III medical devices, ensuring compliance with global regulations and internal standards.
  • Manage the medical device vigilance process, including intake, assessment, and reporting of adverse events, ensuring timely submissions to regulatory authorities.
  • Review and provide safety input for core clinical investigation documents such as Clinical Investigation Plans (CIP/Protocols), Investigator's Brochures (IB), and Reference Safety Information (RSI).
  • Develop and maintain RSI for clinical investigations, ensuring accuracy and timely updates based on emerging safety data.
  • Conduct benefit-risk assessments and provide expert interpretation of clinical safety data to support regulatory and business decisions.
  • Apply and integrate medical device risk management principles in alignment with ISO 14971.
  • Serve as the subject matter expert for safety-related activities within medical device clinical investigations.
  • Ensure compliance with ISO 14155:2020 standards for clinical investigations, particularly regarding safety reporting and subject protection.
  • Provide guidance to clinical teams, investigators, and site staff on safety requirements for medical device studies.

Must-Haves

  • Bachelor's, Master's, or PhD in a scientific field.
  • Minimum 3 years of relevant experience in healthcare, scientific research, or biomedical fields with a focus on clinical safety for medical devices and/or combination products.
  • Strong understanding of the technical aspects of medical devices and applicable regulations.
  • Significant hands-on experience in safety activities for Class II and/or III medical device clinical investigations.
  • Expert-level knowledge and practical application of ISO 14155:2020 across all phases of clinical investigations.
  • Proven ability to develop and lead safety deliverables for clinical investigation documents (CIP/Protocol, IB, RSI).
  • Demonstrated experience in benefit-risk assessment and risk management per ISO 14971.
  • Experience with combination products (drug/device) and medical device vigilance processes.
  • Excellent communication, leadership, and teamwork skills.

Start Date:
1st January or 1st February

Duration:
6 months

Location:
Basel

If you want to learn more about this opportunity please feel free to reach out directly to

*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.

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