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Clinical Expert
hace 2 meses
Job Title: In-House Clinician
About the Role:
We are seeking a highly skilled In-House Clinician to join our team at SGS. As a key member of our clinical team, you will play a crucial role in the conformity assessment process of medical devices.
Key Responsibilities:
- Provide clinical oversight to ensure that our clinical evaluation assessment of Medical Devices complies with EU MDR regulations.
- 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.
- 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.
Requirements:
- A qualified physician with a 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.
