IVDR Clinical Assessor Job At DNV
DNV is hiring an IVDR Clinical Assessor within its Life Sciences business to support conformity assessment of In Vitro Diagnostic (IVD) medical devices under Regulation (EU) 2017/746 (IVDR). This permanent Pharmacy Job role offers the opportunity to assess clinical performance data and contribute to patient safety, regulatory compliance, and global healthcare standards.
Job Details
- Job Title: IVDR Clinical Assessor
- Location: All Locations (Global)
About the Company
DNV is an independent expert in assurance and risk management, committed to safeguarding life, property, and the environment. As a trusted global organization, DNV supports customers across medical devices, healthcare, and life sciences by delivering certification, regulatory assurance, and technical expertise that advance safety, transparency, and sustainability. This Pharmacy Job role plays a significant role in the company.
Educational Requirements
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Degree in one of the following or related fields:
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Pharmacy or Pharmacology
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Key Responsibilities
- Assess and prepare reports on clinical performance aspects of IVD medical devices in accordance with Regulation (EU) 2017/746
- Evaluate summaries of safety and performance for high-risk IVD medical devices
- Review and approve performance evaluation reports and supporting documentation
- Ensure technical documentation meets IVDR requirements for safety and performance
- Form recommendations on certification decisions in complex regulatory cases
Skills Required
- Strong understanding of IVDR (EU 2017/746) requirements
- Experience in assessment of performance evaluation data, including scientific validity and clinical performance
- Excellent analytical and reporting skills
- Strong communication and customer-focused approach
- Ability to work independently and manage complex assessments
- High attention to regulatory compliance and statutory requirements
Why This Job Role?
This Pharmacy Job role provides a unique opportunity to work with a globally respected Notified Body on high-impact regulatory assessments for IVD medical devices. It offers exposure to complex certification decisions, global regulatory frameworks, and collaboration with leading experts in life sciences, while supporting patient safety and healthcare innovation.
