The position is within the Regulatory Affairs Operations organization rather than direct regulatory submission preparation; this role involves supporting Quality System and Compliance initiatives such as Audit Readiness Program Management, including coordination of audit requests, Emerging Regulatory Issues and implementation of conformance, needs involving multiple therapies or device families, Quality System processes, Change Management, CAPAs, International Addendum Labeling controls, Management Review Metrics, etc. Serve as a subject matter expert for International Addendum Labeling requirements and controls, partnering with Shared Services, International Regulatory Affairs, Labeling, Commercial Quality, and Regulatory Affairs to ensure requirements are reflected within the quality system, and business compliance with country-specific requirements.