Proven senior-level experience in CDx development, assessment, regulatory affairs, clinical/performance evaluation, notified body review, pharmaceutical diagnostics strategy, or medicinal product-IVD co-development. * Assess CDx-specific evidence packages, including scientific validity, analytical performance, clinical performance, clinical evidence, benefit-risk rationale, biomarker strategy, patient selection claims, and alignment with the medicinal product indication and labelling. * Identify technical, clinical, and regulatory deficiencies in CDx submissions and drive scientifically robust, risk-based clarification cycles with manufacturers and internal assessment teams. * Collaborate with multidisciplinary , including clinical, regulatory, QMS, software, AI, medi
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