IVDR Product Reviewer

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an IVDR Product Reviewer based in the United States.

Contribute to the safety, quality, and regulatory compliance of in vitro diagnostic (IVD) medical devices by evaluating technical documentation against applicable European regulatory requirements. In this role, you will conduct independent and collaborative assessments of product design dossiers and technical files to determine whether devices meet the requirements for CE marking. You will analyze scientific and technical evidence, assess conformity with relevant standards, and prepare comprehensive reports that support informed certification decisions. Working alongside clinical experts, technical specialists, performance evaluators, and certification project managers, you will help ensure consistent, rigorous, and timely assessments. You will also monitor evolving regulations, share technical knowledge, and contribute to professional training and industry discussions. This opportunity is ideal for an experienced healthcare or medical device professional with strong analytical skills, scientific expertise, and a commitment to impartial evaluation. Your work will help strengthen regulatory confidence and support the availability of safe, effective, and reliable diagnostic technologies.