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. 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-functional experts (e.g. clinical, QMS, software, AI) in multidisciplinary assessment teams Qualification The role requirements are based on IVDR expectations for notified body personnel (e.g. Annex VII competence criteria): University degree in: Medicine, pharmacy, engineering, biology,



microbiology, chemistry, or other relevant biomedical sciences (or equivalent) Expertise in Companion Diagnostics, oncology, or biomarker-based testing is strongly required as well as experience in collaboration with European Medicines Agency (EMA) related to CDx products or drug approvals Four years of professional experience in the field of healthcare products or related activities such as: In vitro diagnostics (IVD) Regulatory affairs / compliance Clinical/performance evaluation Quality management or product development Two years of experience in the design, manufacture, testing or use of devices or technology of IVD products (e.g. in field of cancer, immunohistochemistry, genetic testing, next-generation sequencing, etc.) Solid understanding of IVDR (EU 2017/746) and relevant guidance documents Experience in reviewing or preparing technical documentation is a strong advantage Strong a

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