Act as senior Companion Diagnostics (CDx) subject matter expert for TÜV SÜD, with focus on IVDR conformity assessment, CDx-specific regulatory strategy, and the interface between IVD devices and corresponding medicinal products. * Provide expert input on complex CDx topics such as oncology biomarkers, immunohistochemistry, molecular diagnostics, NGS-based assays, pharmacogenomics, assay bridging, co-development scenarios, and significant changes affecting CDx performance, intended use, or suitability for the medicinal product. * University degree or equivalent qualification in medicine, pharmacy, molecular biology, biotechnology, genetics, pathology, biochemistry, biomedical sciences, engineering, or another discipline directly relevant to Companion Diagnostics. * Deep and demonstrable expertise in Companion Diagnostics, preferably with a strong focus on oncology, biomarker-driven ...
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