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In-House Clinician
hace 3 meses
Job DescriptionAs In-house Clinician, you are a key member of the clinical team within Notified body.
You work together with a group of clinicians and specialized product reviewers for theconformity assessment process of medical device.
With your clinical expertise, you will provide clinical oversight to ensure that our clinical evaluation assessment of Medical Devices complies with EU MDR regulations.
More specifically, you will:To act as the primary clinical expertise within SGS Medical Device certification activitiesReview and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations.Act as coordinator and guide external clinical expert in the clinical assessment and evaluate the resultsBe able to draw records and reports regarding clinical assessment, and make recommendation to notified body's decision makerDevelop, update and maintain appropriate training packages (with a focus of clinical evaluation assessments) for clinical experts and clinical specialists.Offer appropriate clinical input into client queries and meetingsQualificationsEssential: A qualified physicianUniversity degree (Medical Doctor) plus further academic training in a clinically research and/or medical device related area.At least two years experience in the assessment of clinical data for medical devices (closely related products like pharmaceuticals could be considered as well).Fluent in English, reading and writing.Desirable:Knowledge in medical device regulations MDR and related MDCG guidanceWorking experience in medical device industry and knowledge of clinical evaluation and/or clinical investigation
