Medical One Gmbh Jobs

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

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

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

Duration in months (if limited contract):