• Perform CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and ROW • Develop product launch strategy, document testing requirements, submission pathways, and anticipated timelines • Interact with FDA, EU Notified Body, and Health Canada; keep updated on country requirements and changes • Participate in change control meetings; review and approve requests; notify Regulatory Bodies of impactful changes • Perform labeling reviews and approvals • Research and consolidate regulatory requirements to develop regional regulatory strategies • Create and maintain registration procedures/protocols and a foreign registration database • Create 510(k) submissions and submit Q-Submission meetings to FDA as needed • Create Technical Files, Design Dossiers and Health Canada notifications; review and maintain technical documentation • Create New License Submissions, Amendments, and Fax Back applications for Health Canada • Respond to regulatory agency questions during review/submissions • Support external audit program; participate in inspections and audits; complete Regulatory CAPAs • Develop and maintain policies and procedures for regulatory submissions and processes • Partner with international regulatory contacts and internal/external stakeholders to plan, develop, and support submissions • Attend and/or lead regulatory meetings