As In-house Clinician, you are a key member of the clinical team within a Notified Body. You will work together with a group of clinicians and specialized product reviewers for the conformity assessment process of medical devices. 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:
* Act as the primary clinical expertise within SGS Medical Device certification activities.
* Review and scientifically challenge the clinical data contained within the clinical evaluation and any associated clinical investigations.
* Act as coordinator and guide external clinical experts in the clinical assessment and evaluate the results.
* Draw records and reports regarding clinical assessment, and make recommendations to the notified body’s decision maker.
* Develop, update, and maintain appropriate training packages (with a focus on clinical evaluation assessments) for clinical experts and clinical specialists.
* Offer appropriate clinical input into client queries and meetings.
Qualifications:
* University degree (Medical Doctor) plus further academic training in a clinically research and/or medical device related area.
* At least two years of 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.
* Knowledge of medical device regulations MDR and related MDCG guidance.
* Working experience in another notified body or experience in writing or assessing clinical evaluation reports.
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