Job Responsibilities and Qualifications

Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements focused on Companion Diagnostics (CDx) performance evaluation (scientific validity, analytical and clinical performance). Provide instructions for use (IFU) and summary of safety and performance (SSP) and assess applicable IVDR regulatory requirements for Companion Diagnostics, including the consultation procedure involving the European Medicines Agency (EMA). Collaborate with cross‑functional experts (e.g. clinical, QMS, software, AI) in multidisciplinary assessment teams. Expertise in Companion Diagnostics, oncology, or biomarker‑based testing is strongly required as well as experience in collaboration with EMA related to CDx products or drug approvals. Experience in 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 produ...