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

TÜV SÜD; Zürich; On-site; CHF 80,000 - 120,000; Full time

Job summary

TÜV SÜD in Zürich is seeking a professional in Medical Devices & Healthcare to perform Technical Documentation Assessments (TDA) for IVD devices according to IVDR requirements. Your expertise will be central to ensuring compliance and quality in evaluation processes.

The ideal candidate holds a university degree in life sciences or a comparable field, possesses strong analytical skills, and is fluent in English. This position offers a hybrid working model in a diverse and inclusive environment.

Qualifications

• Several years of professional experience in in vitro diagnostics, regulatory affairs, or quality management.
• Solid understanding of IVDR (EU 2017/746) and relevant guidance documents.
• Experience in reviewing or preparing technical documentation is highly desirable.

Responsibilities

• Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements.
• Assess compliance of IVD devices against applicable IVDR provisions.
• Prepare structured assessment reports in line with notified body processes.

Skills

Analytical skills

Technical documentation assessment

Regulatory compliance

Fluency in English

Education

University degree in life sciences, medicine, biology, or biochemistry

Tools

MS Office

Job description

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 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

Qualifications

• 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

Additional Requirements

• Fluent in English (written and spoken)
• Structured and independent working style
• Very good MS Office skills

Diversity & Inclusion

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.

Job Information

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