Vacancy Description
Tasks
- Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements focused on Companion Diagnostics (CDx)
- Assess compliance of IVD devices against applicable IVDR provisions (e.g. Annex I, Annex IX, Annex X/XI)
- Review and evaluate:
- Performance evaluation (scientific validity, analytical and clinical performance)
- Benefit-risk assessment and risk management documentation
- Post-Market Surveillance (PMS / PSUR) documentation
- Instructions for Use (IFU) and Summary of Safety and Performance (SSP)
- Assess applicable IVDR regulatory requirements for Companion Diagnostics, including the consultation procedure involving the European Medicines Agency (EMA).
- Identify deficiencies and participate in iterative review cycles with manufacturers
- Prepare structured assessment reports in line with notified body processes
- Collaborate with cross‑fun...
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