Regulatory Affairs Specialist 2
Philips • Alajuela, Costa Rica
Role Description
**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...
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...