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Clinical Biologist Specialist

Il y a 2 mois


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Job Title: Clinical Biologist Specialist

About the Company: GMED is a leading French notified body and a global reference organization in the evaluation of medical devices (MD) compliance. We also certify quality management systems (QMS) for MD manufacturers.

Job Responsibilities:

  • Contribute to the market launch of new diagnostic tests by utilizing expertise in medical biology.
  • Evaluate the compliance of medical devices-in-vitro diagnostics (MD-IVD) tests and reagents.
  • Determine the need for specialist input in product performance evaluation.
  • Analyze clinical data and provide guidance to selected clinical experts.
  • Assist in the training of internal and external clinical experts.

Requirements:

  • Doctorate in Medicine or Pharmacy with specialization in medical biology.
  • Minimum 4 years of professional experience in the healthcare industry, including 2 years in development, design, or manufacturing of in vitro diagnostic devices.
  • Proficient in written and spoken English.
  • Strong attention to detail, critical thinking, and communication skills.

Additional Skills:

  • Knowledge of MD-IVD regulations.
  • Quality management and performance evaluation expertise.