Medical Device Specialist
4 weeks ago
We are a global benchmark for sustainability, quality, and integrity, with 99,600 employees operating a network of 2,600 offices and laboratories. As an In-House Clinician, you will be a key member of our clinical team within a Notified Body, ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe.
Key Responsibilities- Act as primary clinical expertise within SGS In-Vitro Diagnostic Medical Device certification activities
- Review and scientifically challenge clinical data contained within clinical performance evaluation, and any associated clinical investigations
- Collaborate with clinicians and specialized product reviewers for conformity assessment process of IVD devices in accordance with the EU In-Vitro Diagnostic Medical Devices Regulation 2017/746
- Professional experience in clinical diagnostics, including experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc.
- At least two years of experience relevant to the generation and/or interpretation of performance data for in-vitro diagnostic assays in a clinical setting
- Fluent in English, reading and writing
- Knowledge of the 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 are looking for a highly skilled and experienced In-House Clinician to join our team at SGS. If you have a passion for medical device regulatory affairs and a strong background in clinical diagnostics, we encourage you to apply for this exciting opportunity.
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