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In-House Clinician for Medical Device Certification

hace 2 meses


Madrid Centro, Madrid, España SGS A tiempo completo

About the Role

We are seeking a highly skilled In-House Clinician to join our team at SGS, a leading testing, inspection, and certification company. As a key member of our clinical team, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe.

Key Responsibilities

  1. Primary Clinical Expertise: Act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification activities, providing clinical oversight and ensuring that our assessment of the clinical aspects of IVD devices complies with the requirements of the IVDR.
  2. Clinical Data Review: Review and scientifically challenge the clinical data contained within the clinical performance evaluation, and any associated clinical investigations.
  3. External Expertise Coordination: Coordinate the involvement of external clinical experts in the assessment process, deciding when external expertise is required, guiding the experts in their tasks, and evaluating the results.
  4. Record Keeping and Reporting: Draw up records and reports regarding clinical assessment, and make recommendations to the notified body's decision makers.
  5. Training and Development: Develop, update, and maintain appropriate training packages (with a focus on clinical evaluation assessments) for clinical experts and other team members.
  6. Clinical Input: Offer appropriate clinical input into client queries and meetings.

Requirements

Essential:

  1. Professional experience in the field of clinical diagnostics, including experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc.
  2. University degree in a relevant domain.
  3. At least two years of experience relevant to the generation and/or interpretation of performance data for in-vitro diagnostic assays in a clinical setting.
  4. Fluent in English, reading and writing.

Desirable:

  1. Knowledge of the EU in-vitro medical device regulation (IVDR) and related MDCG guidance.
  2. Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies.
  3. Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies.
  4. A keen interest in medical device regulatory affairs.