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. * Represent TÜV SÜD externally as a recognized CDx expert in scientific and regulatory committees, industry associations, expert panels, conferences, workshops, and customer-facing events. * Collaborate with multidisciplinary , including clinical, regulatory, QMS, software, AI,
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