• Coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices • Perform Regulatory Impact Assessments to determine registration implications for proposed product and design changes • Prepare and submit international regulatory filings in alignment with established timelines and business objectives • Lead and author 510(k) submissions, including applicable technical and regulatory content • Represent Regulatory Affairs on cross-functional projects and provide regulatory guidance throughout development and change management • Collaborate with internal teams to implement and improve regulatory processes, including registration tracking, reporting, and status management • Monitor global regulatory changes and assess their impact on submission strategies and existing registrations • Interact with regulatory authorities as needed during submission and review processes • Coordinate with international partners on product changes, regulatory notifications, and license maintenance • Author or revise SOPs to support ongoing quality system and regulatory compliance • Support audit readiness and other regulatory or quality-related initiatives as assigned