• Develop and execute U.S. regulatory strategies to support product clearance and lifecycle management. • Prepare, submit, and maintain FDA filings (e.g., 510(k), device listings, establishment registration). • Act as primary liaison with the FDA, including participation in meetings and responding to questions post-submission. • Set up and manage U.S. post-market systems: complaints, vigilance, MDR, recalls, and surveillance. • Integrate regulatory requirements into our Quality Management System (Egnyte/ETQ). • Monitor evolving FDA regulations and translate them into actionable guidance. • Collaborate with cross-functional teams (Quality, Engineering, Clinical) to ensure compliance and readiness for scale.