Job Description
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
Qualifications
Essential:
Professional experience in the field of clinical diagnostics. This may include experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc. Professional accreditation and/or active registration with relevant professional societies is highly advantageous University degree in a relevant domain 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
Desirable:
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 Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies A keen interest in medical device regulatory affairs
