Labeling Operations Specialist

Label Operations Specialist

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

This role will be available in Danvers, MA in the United States. Remote work may be eligible. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Purpose:

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.

Principal Duties and 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.

Qualifications

• 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 is preferred.

Benefit Information

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• 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…