Labeling Operations Specialist
About The Position
Johnson & Johnson is seeking a Labeling Operations Specialist to join our team. In this role, you will be responsible for reviewing and processing labeling change requests in accordance with J&J and regulatory standards. You will support cross-functional teams including Regulatory Affairs, Design, Quality and Lifecycle to ensure labeling updates are accurate, compliant, and efficiently managed throughout their lifecycle. Your expertise in navigating change control processes, supporting new product development, and ensuring adherence to global regulations will be critical to maintaining our portfolio’s compliance. This position offers a valuable opportunity to contribute to the execution of labeling strategies on a global scale.
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).
Nice To Haves
- Project management experience is preferred.
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, 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 (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.
Benefits
- medical
- dental
- vision
- life insurance
- short and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
