At a Glance
- Tasks: Conduct assessments on Companion Diagnostics to ensure compliance with IVDR requirements.
- Company: Join TÜV SÜD, a leader in medical technology and healthcare.
- Benefits: Enjoy flexible working hours, competitive salary, and health management programs.
- Other info: Work in a diverse, inclusive environment with excellent career growth opportunities.
- Why this job: Make a real difference in healthcare by evaluating innovative diagnostic products.
- Qualifications: Degree in relevant biomedical sciences and expertise in Companion Diagnostics required.
The predicted salary is between 50000 - 65000 £ per year.
Tasks
- Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements focused on Companion Diagnostics (CDx)
- 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 applicable IVDR regulatory requirements for Companion Diagnostics, including the consultation procedure involving the European Medicines Agency (EMA)
- 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
- University degree in Medicine, pharmacy, engineering, biology, microbiology, chemistry, or other relevant biomedical sciences (or equivalent)
- Expertise in Companion Diagnostics, oncology, or biomarker‑based testing is strongly required as well as experience in collaboration with European Medicines Agency (EMA) related to CDx products or drug approvals
- Four years of professional experience in the field of healthcare products or related activities such as:
- In vitro diagnostics (IVD)
- Regulatory affairs / compliance
- Clinical/performance evaluation
- Quality management or product development
- Two years of experience in the design, manufacture, testing or use of devices or technology of IVD products (e.g. in field of cancer, immunohistochemistry, genetic testing, next‑generation sequencing, etc.)
- Solid understanding of IVDR (EU 2017/746) and relevant guidance documents
- Experience in reviewing or preparing technical documentation 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
We offer flexible working hours, attractive bonuses, and a comprehensive health management programme. We are committed to being an inclusive and diverse employer.
Product Reviewer (IVD - Companion Diagnostics) (w/m/d) employer: TÜV SÜD
TÜV SÜD is an exceptional employer that fosters a culture of innovation and excellence, particularly in the Defence and Aerospace sectors. Located in Fareham, our team enjoys a competitive salary, generous holiday entitlement, and comprehensive wellbeing support, all while working with cutting-edge technologies in a collaborative environment. We prioritise employee growth and inclusivity, ensuring that every team member feels valued and empowered to contribute to meaningful projects that impact society.
