Labeling Operations Specialist

Johnson & Johnson•Danvers, MA

21d•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. 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. Your unique talents will help patients on their journey to wellness. This role will be available in Danvers, MA in the United States. Remote work may be eligible. 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
Company’s 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