Job Description
As an 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 the conformity 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.
This role is fully remote and we are only open to candidates with a valid work permit for the country of their residence.
More Specifically, You Will:
1. Act as the primary clinical expertise within SGS Medical Device certification activities.
2. Review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations.
3. Act as coordinator and guide external clinical expert in the clinical assessment and evaluate the results.
4. Be able to draw records and reports regarding clinical assessment, and make recommendation to Notified Body’s decision maker.
5. Develop, update and maintain appropriate training packages (with a focus of clinical evaluation assessments) for clinical experts and clinical specialists.
6. Offer appropriate clinical input into client queries and meetings.
7. Act as a final reviewer with regards to clinical aspects according to EU MDR regulation.
Qualifications
Essential:
8. A qualified Dentist with minimum two years of working experience is a must have.
9. University degree (Dentistry) plus further academic training in a clinically research and/or medical device related area.
10. Fluent in English, reading and writing.
Desirable:
11. Knowledge of the Medical Device Regulation (MDR) and relevant guidance documents (, MDCG, MEDDEV).
12. At least two years experience in the assessment of clinical data for medical devices in a Notified Body would be a strong advantage.
13. Experience working with a Notified Body and/or experience writing or assessing Clinical Evaluation Reports (CERs).