IVDR Clinical Assessor

Roles & Responsibilities
• Perform clinical and performance assessment of IVD manufacturers’ technical documentation in line with EU IVDR (Regulation (EU) 2017/746)
• Review and assess Scientific Validity, Analytical Performance, and Clinical Performance data
• Prepare and finalize detailed clinical assessment and evaluation reports
• Evaluate Summary of Safety and Performance (SSP) documentation for high-risk IVD devices
• Review and approve Performance Evaluation Reports (PERs) and supporting clinical evidence
• Provide expert recommendations for conformity assessment, certification, and regulatory decisions
• Ensure all assessments comply with Notified Body requirements and DNV quality standards
• Interact with internal teams, manufacturers, and stakeholders to clarify technical and regulatory queries

Qualification
• Biology / Microbiology
• Chemistry / Biochemistry
• Biotechnology / Medical Technology
• Biomedical Sciences (Hematology, Virology, Molecular Diagnostics)
• Pharmacy / Pharmacology / Toxicology
• Medicine / Veterinary Medicine / Nursing / Physiology
• PhD in a relevant discipline may substitute part of the experience requirement

Experience
• Minimum 4 years of full-time experience in IVD medical devices, academia, or hospital settings
• At least 2 years of hands-on experience in performance evaluation of IVD devices or assessment of scientific validity and clinical performance data
• PhD holders may substitute 3 years of experience, provided 2 years are in performance evaluation

Skills
• Strong analytical and scientific assessment capability
• Excellent technical writing and regulatory reporting skills
• In-depth understanding of EU IVDR 2017/746 requirements
• Ability to independently manage complex certification and assessment activities
• Effective communication and stakeholder management skills

About the Company
DNV is a globally trusted assurance and risk management company, operating across healthcare, life sciences, energy, maritime, and industrial sectors. DNV supports organizations in managing risks, ensuring regulatory compliance, and improving safety and sustainability. With a strong focus on quality, integrity, and innovation, DNV provides professionals with structured training, global exposure, and long-term career growth in high-impact regulatory and compliance roles.