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

Innovations bring profound changes and influence our lives in a variety of ways. At the TÜV SÜD Group, we are highly striving to be an important part of this development and progress. We are here from the beginning and accompany this process. We ensure a safe and sustainable future and create confidence in new technologies. We advise, we check, we certify. For the safety of people and society, we are asking ourselves out every day. We act out of conviction, already today shape the world of tomorrow – set signs. We take the future into our hands. We're the TÜV SÜD group. The TÜV SÜD Group has been synonymous with safety, quality and sustainability since 1866 and is today an international service group with 30,000 employees worldwide. Independently and objectively, the TÜV SÜD Group ensures consumer confidence. 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 rational, 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, and integration of scientific opinions into the certification. Provide expert input on complex CDx topics such as oncology biomarkers, immunhistochemistry, molecular diagnostics, NGS-based assays, pharmacogenomics, assay bridging, co-development scenarios, and significant changesing 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 reporting cycles with manufacturers and internal assessment teams. Representative 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, and internal competence-building. 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.

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 approval, biomarker-based patient selection, or scientific consultation is desirable. Ability to critically evaluate complex scientific and clinical evidence, including biomarker rational, assay validation, 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. Date of birth: Fluent in English (written and spoken) Structured and independent working style Very good MS Office skills

Flexible working hours: Our flexible working hours allow you to adapt your working hours to your personal needs. Special payments: In addition to a market-oriented salary, we offer attractive special payments such as e.g. a consolidated profit premium or other performance-oriented salary components. Operational Health Management: Our operational health management includes e-Gym Wellpass, which provides you with access to a variety of fitness and health services, as well as an occupational pension scheme that helps you to provide care for your future. Further Benefits: Learn more about our numerous other benefits at https://www.tuvsud.com/de-de/karriere/was-wir-biet At the TÜV SÜD Group, people from more than 100 nations work together. People with different backgrounds, skills and goals. Our strength lies in these numerous and diverse perspectives. We commit ourselves to being an inclusive and diverse employer by welcoming all people. Diversity and integration is the foundation of our company and we promote an environment where all our employees can trust that You are treated with respect - regardless of age, nationality, ethnic background, disability, gender and gender identity or sexual orientation, religion or worldview. We expect our employees to behave at any time in accordance with the Ethics Code of the TÜV SÜD Group and the company values. Applications for people with disabilities are expressly desired and are considered preferred if You are otherwise essentially of the same suitability. We firmly believe that the constant 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. .