Regional Labeling & IFU System Analyst

Posted 5 Days Ago
Be an Early Applicant
4 Locations
In-Office
94K-170K Annually
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Support and sustain regional labeling and Instructions for Use (IFU) systems across multiple sites. Manage change request intake and execution, support new product introductions and transfers, translate global customer and regulatory requirements into functional system designs, drive harmonization and compliance, execute content and process updates, and communicate business issues. Collaborate across matrixed teams to improve end-to-end supply chain processes and ensure data accuracy and validation.
Summary Generated by Built In

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Packaging Design Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy Synthes is recruiting for an  Regional Labeling & IFU System Analyst, located in Raynham, MA, Warsaw, IN, Palm Beach, FL and West Chester, PA. 

The Regional Labeling and IFU System Analyst is responsible for supporting global supply chain labeling systems and IFUs planning and execution processes This includes support necessary to sustain daily regional labeling operations as well as changes driven by new product introductions, continuous improvement initiatives, product transfers and regional regulatory changes. This role offers exposure to integrated supply chain processes and provides a strong foundation for career growth within Supply Chain & Operations. 

Key Responsibilities 

  • Oversee all processes associated with the ongoing support of regional label and IFU systems. This includes change request intake and execution as well as day-to-day system support 

  • Supports all activities associated with the identification, development and deployment of updates to existing label & IFU systems or new label & IFU systems. 

  • Responsible for understanding global customer requirements and translating those requirements into specific functional design options for global capabilities supported by the technology solution.   

  • Strive towards global process and system harmonization while maintaining compliance with regional and global regulations. 

  • Proactively responds to emerging regional and global regulations and/or business requirements through the execution of content and process updates. 

  • Responsible for communicating business issues or opportunities to next management level 

  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures 

  • Performs other duties assigned as needed 

Qualifications 

Education 

  • Bachelor’s degree required, preferably in Supply Chain, Operations Management, Business Management, Engineering, Analytics, or a related field. 

  • 5+ Years of relevant work experience is required. 

Experience and Skills 

Required: 

  • Labeling, Operations and Supply Chain experience is preferred. 

  • Experience working in a matrix environment across geographies and organizations is preferred. 

  • Experience within New Product Development, Lifecyle Management, Manufacturing Processes and Quality is preferred 

  • Demonstrated understanding of an end-to-end Supply Chain,  

  • Medical Device knowledge is required 

  • Understanding Labeling and Packaging design & requirements is preferred.  

  • Understanding Regulations and Standards for labeling is preferred. 

  • Knowledge of validation requirements for Medical Devices with demonstrated experience is preferred. 

  • Knowledge of validation requirements for software systems with demonstrated experience is preferred.  

  • Proven experience in developing and implementing strategies to drive E2E processes and efficiencies. 

  • Ability to follow defined processes and standard operating procedures. 

  • Attention to detail and a commitment to data accuracy and compliance. 

  • Change Management experience preferred 

  • Excellent communication, coping and interpersonal skills to motivate and persuade impacted team members including the ability to make complex issues easy for others to understand and the ability to prepare communications for project team and management are required.   

Preferred: 

  • Exposure to supply chain planning systems (e.g., ERP, planning or inventory tools). 

  • Experience working in a regulated or manufacturing environment. 

  • Interest in continuous improvement or operational excellence methodologies. 

  • Strong communication skills and the ability to collaborate across teams. 

Other: 

  • Language: English proficiency required. 

  • Travel: Minimal travel (generally <15%), primarily domestic. 

  • Certifications: None required. 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

 

 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. 

  

#LI-Hybrid 

#DePuySynthesCareers

Required Skills:



Preferred Skills:

Coaching, Critical Thinking, Detail-Oriented, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Quality Assurance (QA), Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Sustainability, Sustainable Packaging, Technologically Savvy, Validation Testing

The anticipated base pay range for this position is :

$94,000.00 - $170,000.00

Additional Description for Pay Transparency:

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)). 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 period10 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

Skills Required

  • Bachelor's degree (Supply Chain, Operations, Business, Engineering, Analytics or related)
  • 5+ years of relevant work experience
  • Medical device knowledge
  • Demonstrated understanding of end-to-end supply chain
  • Proven experience developing and implementing E2E process improvements and efficiencies
  • Ability to follow defined processes and standard operating procedures
  • Attention to detail and commitment to data accuracy and compliance
  • Excellent communication and interpersonal skills, able to simplify complex issues
  • English proficiency
  • Labeling, operations and supply chain experience
  • Experience in matrixed, cross-geography environments
  • Knowledge of validation requirements for medical devices and software systems
  • Understanding of labeling and packaging design, regulations, and standards
  • Change management experience

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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