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. * Support and, where appropriate, lead the notified body consultation process with EMA or national competent authorities for medicinal products, including preparation and review of consultation packages, management of authority questions, and integration of scientific opinions into the certification decision. * Represent TÜV SÜD externally as a recognized CDx expert in scientific and regulatory committees, industry associations, expert panels, conferences, workshops, and customer-facing events. * Experience with EMA or national competent authority int
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