Medical Device Specialist
3 weeks ago
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
- 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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