As a Senior Regulatory Affairs Engineer at Neko Health, you will assign product codes and IDs, own product registrations, maintain establishment listings and reporting, manage legal representatives, drive regulatory intelligence, support product development, and empower process owners and teams. Your role involves keeping registrations of multiple devices in multiple markets current.
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Ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market. You will advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. You will also prepare and submit documentation for EU MDR, FDA, and other international markets.