Senior Manager

• Prepare, review, and maintain regulatory dossiers and technical documentation for domestic and international markets. • Support submissions for EU IVDR, WHO PQ, ANVISA, and other applicable regulatory frameworks. • Coordinate with QA, R&D, Manufacturing, and Marketing for regulatory compliance and submission requirements. • Review product changes, labeling, claims, and supporting documents from a regulatory perspective. • Monitor updates in global regulations and support implementation of app…