IVD Technical Documentation Reviewer (IVDR)

TÜV SÜD; Zürich; Hybrid; CHF 80.000 - 120.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Analytical skills

Technical documentation assessment

Regulatory compliance

Fluency in English

Ausbildung

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

Tools

MS Office

Jobbeschreibung

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.