At TÜV SÜD Group we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group.
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.
Qualification :
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
At TÜV SÜD Group, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives.
We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Group Code of Ethics and Company values.
We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD Group. Click here to find out more about Diversity at TÜV SÜD Group.
Work Area: Medical Devices & Healthcare
Country/Region: Germany, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
Job Location: München, Hamburg, San Diego, Madrid, Lisbon, London, Warsaw, Newcastle, Zürich
Working Model: Hybrid
Employment Type: Full time or part time / regular
Company: TÜV SÜD Produkt Service GmbH
Org Unit Code: PS-MHS-PA
Requisition ID: 5685
Duration in months (if limited contract):
