Product Reviewer (IVD – Companion Diagnostics) (w/m/d)
Core
Senior subject matter expert for Companion Diagnostics (CDx) performing IVDR conformity assessments, regulatory strategy, and technical documentation reviews for CDx devices and their associated medicinal products.
Role type
Senior IC regulatory affairs expert (Companion Diagnostics)
Builds
IVDR-compliant certification decisions and regulatory strategies for CDx devices
Domain
Medical Devices / Companion Diagnostics / Oncology / Molecular Diagnostics
Required skills
IVDR regulatory strategy, CDx technical documentation assessment, clinical performance evaluation, biomarker strategy, EMA/national authority consultation, oncology biomarkers, NGS-based assays, pharmacogenomics, risk-based clarification cycles, scientific validity assessment
Preferred skills
Notified Body experience, medicinal product-IVD co-development, MDCG/EMA guidance interpretation, cross-functional expert leadership
Technologies
NGS, Immunohistochemistry, Molecular Diagnostics, Pharmacogenomics
Responsibilities
Perform and guide Technical Documentation Assessments for CDx devices in accordance with IVDR requirements; Assess CDx-specific evidence packages including scientific validity and clinical performance; Support and lead notified body consultation processes with EMA or national competent authorities; Provide expert input on complex CDx topics such as oncology biomarkers and NGS-based assays; Identify technical, clinical, and regulatory deficiencies in CDx submissions; Represent TÜV SÜD externally as a recognized CDx expert in scientific and regulatory committees; Contribute to thought leadership by preparing presentations and training material; Collaborate with multidisciplinary experts to ensure consistent CDx assessments
Seniority
Senior, hands-on IC