"Alerted.org

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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub** **Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

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 Labeling Compliance Specialist.

**Purpose** : Johnson & Johnson is seeking an experienced and detail-oriented professional to join our team as a Labeling Compliance Specialist. This individual will ensure compliance with all relevant regulations and standards related to product labeling, while contributing to the development, assessment, and lifecycle management of labeling strategies. They will collaborate with cross-functional teams including Regulatory, Clinical, Quality, Design, and Lifecycle to evaluate changes for new product launches and revisions. With a strong background in project management and a solid understanding of regulatory standards for medical devices, they will oversee labeling initiatives to ensure our portfolio remains compliant. This role offers an exciting opportunity to influence product compliance on a global scale.

Principal Duties and Responsibilities:

+ Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures related to product labeling and instructions for use (IFU).

+ Complete the Label Assessment, including redlining artwork, file creation, and translation management.

+ Serve as the point person for New Product Development and Lifecycle teams in executing labeling strategies and project plans, supporting label and IFU development for new product launches and lifecycle revisions.

+ Lead collaboration efforts to gather requirements and align on label strategy and content with Regulatory, Clinical, Quality, R&D, and Product Lifecycle teams as required.

+ Work with labeling execution planning to align project plans with team schedules, escalating capacity constraints and facilitating prioritization, capacity augmentation, or timeline adjustments in coordination with project teams and business units.

+ Execute Design Control documentation and ensure proper implementation for label development.

+ Govern the Intake Process for new labeling projects to ensure adequate resourcing and prioritization.

+ Manage the cadence for lifecycle changes to ensure labeling across the portfolio remains compliant.

+ Lead Labeling Program Management for larger, complex projects by developing timelines and identifying potential risks.

Qualifications:

+ Bachelors Degree

+ 5+ Years Work Experience

+ Demonstrated track record of Project Management

+ Demonstrated ability to manage several projects simultaneously

+ Demonstrated ability to lead a cross-functional cross region team preferred.

+ Demonstrated understanding of Medical Device or equivalent regulated industry, Quality Systems and Change Control procedures preferred.

+ Strong correspondence and documentation composing skills

+ Strong written and oral communication skills

+ Domestic and international regulatory and legal regulations

+ Change Management concepts and methods

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.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: