Clinical Expert

1 week ago

London, Greater London, United Kingdom SGS Full time
Job Description

We are SGS, a leading testing, inspection, and certification company. Our mission is to enable a better, safer, and more interconnected world. As a key member of our clinical team, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe.

Key Responsibilities
  • Clinical Expertise: Act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification activities, reviewing and scientifically challenging clinical data contained within the clinical performance evaluation, and any associated clinical investigations.
  • External Expertise: Coordinate the involvement of external clinical experts in the assessment process, deciding when external expertise is required, guiding the experts in their tasks, and evaluating the results.
  • Record Keeping: Draw up records and reports regarding clinical assessment, and make recommendations to the notified body's decision makers.
  • Training and Development: Develop, update, and maintain appropriate training packages for clinical experts and other team members.
  • Clinical Input: Offer appropriate clinical input into client queries and meetings.
Requirements
  • Professional Experience: Professional experience in the field of clinical diagnostics, including experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc.
  • Education: University degree in a relevant domain.
  • Language Skills: Fluent in English, reading and writing.
Desirable Qualifications
  • Regulatory Knowledge: Knowledge of the EU in-vitro medical device regulation (IVDR) and related MDCG guidance.
  • Industry Experience: Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies.
  • Investigations Experience: Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies.
  • Regulatory Affairs: A keen interest in medical device regulatory affairs.

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