IN-HOUSE CLINICIAN, GLOBAL MEDICAL DEVICES

As In-house Clinician, you are a key member of the clinical team within a Notified Body, which acts to ensure the safety and efficacy of in-vitro diagnostic medical devices available in Europe. You will act as a key decision maker in ensuring that IVD devices sold in the EU provide relevant clinical benefits, minimise risks to the patients and reflect the state of the art in clinical diagnostics.

You will work together with a group of clinicians and specialized product reviewers for the conformity assessment process of IVD devices in accordance with the EU In-vitro Diagnostic Medical Devices Regulation 2017/746. You will support the technology experts on the team with your clinical knowledge to provide clinical oversight and ensure that our assessment of the clinical aspects of IVD devices complies with the requirements of the IVDR.

Specific Responsibilities:

• Act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification activities
• Review and scientifically challenge the clinical data contained within the clinical performance evaluation, and any associated clinical investigations
• 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
• Draw up records and reports regarding clinical assessment, and make recommendation to the notified body’s decision makers
• Develop, update and maintain appropriate training packages (with a focus of clinical evaluation assessments) for clinical experts and other team members
• Offer appropriate clinical input into client queries and meetings