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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The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders, serving as the global regulatory lead for the multifocal motor neuropathy (MMN) program and supporting other programs as needed. You will provide expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.
We’re seeking a Manager of Regulatory Affairs to support ARMRA’s compliance efforts across product lines, marketing, and operations. This role requires strong knowledge of dietary supplement regulations and the ability to collaborate effectively with cross-functional teams. Reporting to the Senior Director of Regulatory Affairs, you’ll work closely with Marketing, Product Development, Quality Assurance, and Science teams to ensure compliance.