Clinical Expert

hace 1 día

Zaragoza, Zaragoza, España Sgs A tiempo completo
Job Description

Sgs is seeking a highly skilled Clinical Expert to join our team as an In-House Clinician, Global Medical Devices. 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:
  • Act as the primary clinical expertise within Sgs In-vitro Diagnostic Medical Device certification activities.
  • Review and scientifically challenge the clinical data contained within the clinical performance evaluation, and any associated clinical investigations.
  • 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.
  • Draw up records and reports regarding clinical assessment, and make recommendations to the notified body's decision makers.
  • Develop, update and maintain appropriate training packages (with a focus on clinical evaluation assessments) for clinical experts and other team members.
  • Offer appropriate clinical input into client queries and meetings.
Requirements:
  • Professional experience in the field of clinical diagnostics.
  • Professional accreditation and/or active registration with relevant professional societies is highly advantageous.
  • University degree in a relevant domain.
  • 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.
  • Fluent in English, reading and writing.
Desirable:
  • Knowledge of the EU in-vitro medical device regulation (IVDR) and related MDCG guidance.
  • Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies.
  • Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies.

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