Product Reviewer (IVD – Companion Diagnostics) (w/m/d)

TÜV SÜD AG; München; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

TÜV SÜD is seeking a senior Companion Diagnostics (CDx) expert to lead IVDR conformity assessments and strategic regulatory guidance for CDx devices. You will review technical documentation, coordinate with EMA and national authorities, and provide expert input on oncology biomarkers, NGS-based assays, and biomarker-driven therapies, ensuring alignment with product indications and labeling.

Independent, cross-functional collaboration and external representation in committees and industry events

Qualifikationen

• Deep expertise in Companion Diagnostics with oncology focus.
• Senior-level experience in CDx development, assessment, and regulatory affairs.
• Proven experience with EMA or national authority interactions related to CDx.
• Strong ability to translate complex CDx topics into clear guidance and materials.
• Independent, analytical thinker with strong stakeholder management.
• Notified Body experience is helpful.

Aufgaben

• Act as senior CDx SME for TÜV SÜD with focus on IVDR conformity assessment.
• Perform and guide Technical Documentation Assessments for CDx devices.
• Lead and participate in notified body consultations with EMA or authorities.
• Provide input on oncology biomarkers, immunohistochemistry, NGS-based assays.
• Identify deficiencies in submissions and drive risk-based clarifications.
• Represent TÜV SÜD externally in committees, panels, and events.
• Develop presentations, position papers, and training materials.

Kenntnisse

Companion Diagnostics

IVDR expertise

Regulatory strategy

Notified Body procedures

Cross-functional leadership

English proficiency

Ausbildung

Medicine (MD)

Pharmacy

Molecular biology

Biotechnology

Biomedical sciences

Engineering

Tools

MS Office

Jobbeschreibung

Beginn

Tasks

• 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.
• Perform and guide Technical Documentation Assessments for CDx devices in accordance with IVDR requirements, including classification as at least class C, intended purpose, suitability in relation to the medicinal product, and applicable conformity assessment routes.
• 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.
• 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.
• Identify technical, clinical, and regulatory deficiencies in CDx submissions and drive scientifically robust, risk-based clarification cycles with manufacturers and internal assessment teams.
• Represent TÜV SÜD externally as a recognized CDx expert in scientific and regulatory committees, industry associations, expert panels, conferences, workshops, and customer-facing events.
• Contribute to TÜV SÜD’s CDx thought leadership by preparing presentations, position papers, training material, interpretation guidance, and internal competence-building activities.
• Collaborate with multidisciplinary experts, including clinical, regulatory, QMS, software, AI, medicinal product, and biomarker specialists, to ensure consistent and high-quality CDx assessments across projects.

Qualifications

The role requirements are based on IVDR expectations for notified body personnel (e.g. Annex VII competence criteria):

• 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 therapies, molecular diagnostics, immunohistochemistry, NGS, or pharmacogenomic testing.
• 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.
• Strong understanding of IVDR requirements for CDx, including Article 2(7), Article 48, Annex VIII classification rules, Annex IX/Annex X consultation pathways, Annex XIII performance evaluation principles, and relevant MDCG, EMA, and Team‑NB guidance or position papers.
• Experience with EMA or national competent authority interactions related to CDx, medicinal product authorisation, biomarker-based patient selection, or scientific consultation procedures is highly desirable.
• Ability to critically evaluate complex scientific and clinical evidence, including biomarker rationale, assay validation, clinical validity, clinical utility, patient stratification, drug label alignment, and post‑market evidence generation.
• Recognized professional credibility and communication strength to represent TÜV SÜD in external committees, expert groups, industry events, regulatory workshops, customer meetings, and scientific forums on CDx topics.
• Strong ability to translate complex CDx regulatory and scientific topics into clear guidance, presentations, training material, and strategic recommendations for internal and external stakeholders.
• High level of independence, analytical judgement, stakeholder management capability, and confidence in leading cross‑functional expert discussions in a notified body environment.
• Notified Body experience is considered helpful.

Additionally:

• Fluent in English (written and spoken)
• Structured and independent working style
• Very good MS Office skills