Labeling Operations Specialist

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. Learn more at jnj.com

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.

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About Cardiovascular

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.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This is 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.

We are searching for the best talent for a Label Operations Specialist.

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 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 10 days

• Volunteer Leave – 32 hours per calendar year

• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to:

• https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 10/16/2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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