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Clinical Biologist Specialist
Il y a 2 mois
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.