Labeling Operations Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About Cardiovascular

Fueled by innovation at the intersection of biology and technology were 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 thats 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 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 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 portfolios 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:

• Bachelors degree or equivalent work experience 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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:

• job posting is anticipated to close on 2/16/2026. The Company may however extend this time-period in which case the posting will remain available on 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 internal employees contact AskGS to be directed to your accommodation resource.

  Required Skills:

  Preferred Skills:

  Accelerating Analytical Reasoning Coaching Communication Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Manufacturing Science and Technology (MSAT) Problem Management Project Engineering Project Schedule Report Writing Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy

  The anticipated base pay range for this position is :

  $79000.00 - $127650.00

  Additional Description for Pay Transparency: