IVDR Product Reviewer

📋 Description

• Conduct CE type examinations and design dossier or product assessments for in vitro diagnostic
• Independently review or collaborate with other evaluators to assess technical documentation, design
• Evaluate the evidence submitted by manufacturers to determine whether devices meet applicable
• Prepare comprehensive, accurate, and evidence-based assessment reports that clearly document
• Collaborate with product reviewers, clinical experts, performance evaluators, process specialists
• Consolidate assessment findings and communicate technical conclusions clearly to ensure

🎯 Requirements

• A university or technical college degree, or an equivalent qualification, in a relevant discipline
• At least four years of professional experience in healthcare products or related activities
• At least two years of experience in the design, manufacture, testing, or use of the medical device
• Understanding of medical device and in vitro diagnostic regulatory requirements, particularly the
• Ability to review complex technical documentation, interpret scientific evidence, evaluate product
• Strong critical reasoning skills and the ability to apply scientific knowledge, technical

🎁 Benefits

• Full-time, exempt position with an expected workload of at least 40 hours per week.
• Flexibility to work remotely from within the United States, with potential activities at client
• Contribute to the evaluation of medical technologies that support patient safety, diagnostic
• Opportunities to deepen expertise in IVD technologies, technical documentation assessment, CE
• Work with clinical experts, technical specialists, performance evaluators, and certification
• Participate in technical workshops, regulatory discussions, standardization activities, and