Product Reviewer - Technische Dokumentation IVD (f/m/d) - #46599

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

• Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements
• Assess compliance of IVD devices against applicable IVDR provisions (e.g. Annex I, Annex IX, Annex X/XI)
• Review and evaluate:
• Performance evaluation (scientific validity, analytical and clinical performance)
• Benefit-risk assessment and risk management documentation
• Post-Market Surveillance (PMS / PSUR) documentation
• Instructions for Use (IFU) and Summary of Safety and Performance (SSP)
• Assess specific regulatory requirements for Companion Diagnostics, including interaction with medicinal product evaluation processes
• Identify deficiencies and participate in iterative review cycles with manufacturers
• Prepare structured assessment reports in line with notified body processes
• Collaborate with cross-functional experts (e.g. clinical, QMS, software, AI) in multidisciplinary assessment teams
  

Qualification

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

• University degree in:
• Life sciences, medicine, biology, biochemistry, or a comparable discipline
• Several years of professional experience in one or more of the following areas:
• In vitro diagnostics (IVD)
• Regulatory affairs / compliance
• Clinical/performance evaluation
• Quality management or product development
• Solid understanding of IVDR (EU 2017/746) and relevant guidance documents
• Experience in reviewing or preparing technical documentation is highly desirable
• Expertise in Companion Diagnostics, oncology, or biomarker-based testing is a strong advantage
• Strong analytical skills and ability to assess complex scientific data
  

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: Hamburg, Lisbon, London, Madrid, München, Newcastle, San Diego, Warsaw, 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