• Develop, author, assemble, publish and submit IDE Annual Reports, Post-Approval Study Annual Reports, and PMA Annual Reports. • Work collaboratively with subject matter experts and business partners to identify and gather data required for submission. • Monitor regulatory changes and assess their impact on organizational processes and products. • Review and approve technical documentation to ensure alignment with the PMAs. • Maintain FDA device listing and site registration. • Collaborate with stakeholders such as R&D, Engineering, Quality, Clinical and Operations teams.