Medical Device Specialist

3 weeks ago


London, Greater London, United Kingdom SGS Full time
Join SGS as an In-Vitro Diagnostic Medical Device Specialist

We are a global leader in sustainability, quality, and integrity, with 99,600 employees operating in 2,600 offices and laboratories worldwide. As an In-Vitro Diagnostic Medical Device Specialist, you will be a key member of our clinical team, ensuring the safety and efficacy of medical devices available in Europe.

Key Responsibilities:
  • Act as primary clinical expertise for SGS In-Vitro Diagnostic Medical Device certification activities
  • Review and scientifically challenge clinical data contained within clinical performance evaluation and clinical investigations
  • Collaborate with clinicians and product reviewers for conformity assessment of IVD devices in accordance with EU In-Vitro Diagnostic Medical Devices Regulation 2017/746
Requirements:
  • Professional experience in clinical diagnostics, including experience as a physician, clinical pathologist, clinical scientist, or biomedical scientist
  • At least two years of experience in generating and/or interpreting performance data for in-vitro diagnostic assays in a clinical setting
  • Fluent in English, reading and writing
  • Knowledge of EU In-Vitro Medical Device Regulation (IVDR) and related MDCG guidance
  • Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies
  • A keen interest in medical device regulatory affairs

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please apply for this exciting opportunity to join our team at SGS.



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