Labeling Operations Specialist

Labeling Operations Specialist – Danvers, MA

Johnson & Johnson is seeking a Labeling Operations Specialist to review and process labeling change requests in accordance with J&J and regulatory standards. The role supports cross‑functional teams including Regulatory Affairs, Design, Quality, and Lifecycle to ensure labeling updates are accurate, compliant, and efficiently managed throughout their lifecycle.

• 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, including label and IFU development for new product launches and lifecycle revisions.
• 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 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.

• 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).
• Project management experience preferred.

Eligible for company‑sponsored benefits including medical, dental, vision, life insurance, disability, retirement plans, and a long‑term incentive program.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state or local law.

The job posting is anticipated to close on 10/16/2025.