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, 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‑functional experts (e.g. clinical, QMS, software, AI) in multidisci...