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In-House Clinician

hace 3 meses

Madrid, España SGS A tiempo completo
Job Description

As 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 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 expert in the clinical assessment and evaluate the results Be able to draw records and reports regarding clinical assessment, and make recommendation to notified body’s decision maker Develop, 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 meetings

Qualifications

Essential:

A qualified physician University 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 guidance Working experience in medical device industry and knowledge of clinical evaluation and/or clinical investigation