Labeling Operations Specialist

About This Role

This role is responsible for reviewing and processing labeling change requests in accordance with Johnson & Johnson and regulatory standards. The specialist will support cross-functional teams to ensure labeling updates are accurate, compliant, and efficiently managed throughout their lifecycle, contributing to global labeling strategies.

Responsibilities

• Receive, review, and process labeling change requests in accordance with J&J and regulatory standards
• Support the review and redlining of artwork and files, participating in cross-functional review meetings
• Initiate, track, and close change requests within the QMS
• Support New Product Development and Lifecycle teams in executing labeling strategies and project plans
• Assist in collecting and documenting labeling requirements, supporting project plans, and aggregating supporting documentation
• Govern the Intake Process for new labeling projects to ensure adequate resourcing and proper prioritization
• Manage the cadence for lifecycle changes to ensure labeling across the portfolio remains compliant
• Collaborate with Regulatory Affairs (RA) to verify labeling text, graphics, layout, and symbols for accuracy, completeness, and compliance with country-specific requirements
• Identify opportunities to streamline change request workflows
• Ensure labeling updates comply with FDA, EU MDR, ISO, and other global regulations

Requirements

• Bachelor's degree in a relevant field
• 4+ years of experience supporting labeling or regulatory operations
• Experience in cross-functional collaboration
• Exposure to medical devices, regulatory compliance, and change control processes
• Strong written and oral communication skills
• Knowledge of global regulatory standards (FDA, EU MDR, ISO)

Qualifications

• Bachelor's degree in a relevant field
• 4+ years of experience supporting labeling or regulatory operations

Nice to Have

• Project management experience

Skills

* Required skills

Benefits