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

About the company

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 Performa...