**Regulatory Affairs Operations Specialist 2**
This role supports the implementation of regulatory strategies and submissions for smaller-scale projects, coordinating cross-functional efforts to ensure compliance, streamline approvals, and maintain audit-ready documentation throughout the product lifecycle.
**Your role:**
+ Supports implementation of regulatory strategies for smaller, less complex projects by collaborating with regulatory and cross-functional SMEs; assists in preparing and coordinating product submissions, conformity assessments, and change control processes to expedite approvals and maintain compliance.
+ Reviews labeling, marketing communications, and development quality reports to ensure regulatory compliance; maintains documentation to support regulatory filings, audits, and UDI/GTIN-related activities.
+ Works closely with internal teams and regional regulatory partners to align on regulatory standards, support establishment registrations, and advis...