DNV, a globally trusted assurance and risk management company, is hiring an IVDR Clinical Assessor in Hyderabad, Telangana (Hybrid). This full-time opportunity is ideal for professionals with experience in In Vitro Diagnostic (IVD) medical devices, clinical performance evaluation, and EU IVDR (Regulation (EU) 2017/746) compliance. The role focuses on assessing performance evaluation data to ensure safety, performance, and regulatory compliance of IVD medical devices prior to EU market placement.
This IVDR Clinical Assessor job at DNV offers exposure to high-impact regulatory assessments, a strong professional network, and a structured training and qualification program—making it a highly attractive career move for RAQA, regulatory affairs, and clinical evaluation professionals.
Key Responsibilities
- Perform clinical and performance assessment of IVD manufacturers’ technical documentation as per EU IVDR 2017/746.
- Review and prepare assessment reports on Scientific Validity, Analytical Performance, and Clinical Performance.
- Evaluate Summary of Safety and Performance (SSP) documentation for high-risk IVD devices.
- Review and approve Performance Evaluation Reports (PERs) and related clinical evidence.
- Provide expert recommendations on conformity assessment and certification decisions.
- Ensure assessments meet Notified Body requirements and DNV quality standards.
Required Qualifications & Experience
Education (any relevant discipline):
- Biology / Microbiology
- Chemistry / Biochemistry
- Biotechnology / Medical Technology
- Biomedical Sciences (Hematology, Virology, Molecular Diagnostics)
- Pharmacy, Pharmacology, Toxicology
- Medicine, Veterinary Medicine, Nursing, Physiology
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 in a relevant discipline may substitute 3 years of experience, provided it includes 2 years in performance evaluation.
Key Skills & Competencies
- Strong analytical and scientific assessment skills
- Excellent technical writing and reporting abilities
- Sound understanding of EU IVDR regulatory requirements
- Ability to work independently on complex certification cases
- Effective stakeholder and customer communication skills
Salary & Benefits
Estimated Salary Range: ₹15,00,000 – ₹22,00,000 per annum (based on experience and qualifications)
Benefits Include:
- Competitive compensation and annual bonus/profit share
- Comprehensive medical insurance & annual health check-ups
- Paid leaves (annual, sick, maternity/paternity, medical)
- DNV training & qualification programs
- Pension, group term life & accident insurance
- Flexible hybrid work arrangements
- Long service awards and mobile reimbursement
Job Location
Hyderabad, Telangana, India (Hybrid work model)
