Senior Regulatory Affairs Specialist

Position Summary:

This position provides international regulatory leadership and is primarily responsible for securing and maintaining regulatory approvals and registrations for medical devices outside the United States. The role develops and executes international regulatory strategies, manages submissions and post-approval activities, coordinates with distributors and third-party regulatory partners, and assesses product and process changes for impact on international markets.

Duties & Responsibilities:

• Manage and track international regulatory approvals, registrations, renewals, amendments, and related post-approval activities.
• Prepare, coordinate, and submit regulatory applications for direct international markets.
• Support distributors, authorized representatives, and third-party regulatory consultants with submissions and registrations in non-direct international markets.
• Serve as the primary Regulatory Affairs contact for routine international distributor, consultant, and sales communications.
• Author and review international regulatory submissions and supporting documentation, ensuring content is accurate, organized, scientifically sound, and completed within established timelines.
• Assess product, labeling, manufacturing, supplier, and process changes for impact on international registrations and determine applicable notification, approval, or documentation requirements.
• Maintain current knowledge of international regulations, guidance documents, standards, and market-specific requirements; communicate relevant changes and potential impacts to internal stakeholders.
• Collaborate with Quality, R&D, Clinical, Manufacturing, Commercial Sales, and other cross-functional teams to obtain documentation and support international regulatory and market access objectives.
• Maintain international registration records, trackers, and supporting documentation in accordance with internal procedures.
• Other duties as needed or required.