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

About the role

The role requires a senior Companion Diagnostics (CDx) subject matter expert who focuses on IVDR conformity assessment, CDx-specific regulatory strategy, and the interface between IVD devices and corresponding medicinal products.

Responsibilities

• 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.

Requirements

• 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.
• Able 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.

Qualifications

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

Benefits

Flexible working hours: Our flexible working hours allow you to adjust your work schedule according to your personal needs.

Special bonuses: In addition to a market-relevant salary, we offer attractive special bonuses such as a bonus for achieving company goals or other performance-oriented remuneration components.

Corporate health management: Our corporate health management includes, among others, the e-Gym Wellpass, which provides access to a variety of fitness and health offers, as well as a corporate pension plan that helps you prepare for your future.

We also offer numerous additional benefits. Learn more about our extensive range of benefits at https://www.tuvsud.com/de-de/karriere/was-wir-bieten.

What we offer

At the TÜV SÜD Group, people from more than 100 countries work together. People with different backgrounds, skills, and goals. Our strength lies in these various and diverse perspectives.

We commit ourselves to being an inclusive and diverse employer by welcoming all people. Diversity and integration are the foundation of our company, and we foster an environment where all our employees can trust that they will be treated with respect - regardless of age, nationality, ethnic background, disability, gender, gender identity, or sexual orientation, religion, or worldview. We expect our employees to behave in accordance with the TÜV SÜD Group Code of Conduct and the company values at all times.

We are firmly convinced that the continuous anchoring of these values will continue to contribute significantly to the success of the TÜV SÜD Group. Click here to learn more about diversity at the TÜV SÜD Group.