Manager, Global UDI

Antler; Raritan (NJ); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time – 40 hours/year

Parental Leave – 480 hours

Job summary

Johnson & Johnson / DePuy Synthes is seeking a Manager, Global UDI, to lead a global UDI program ensuring regulatory compliance, data integrity, and system readiness across orthopedic portfolios. The role collaborates with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to drive scalable UDI processes.

The position emphasizes governance, quality controls, and readiness for regulatory inspections, with travel up to 10–20% and global impact on patient safety and product

Qualifications

• Bachelor's degree in a relevant field is required
• Master's degree preferred in a scientific, technical, or business discipline
• 6–8 years of experience in QA, regulatory compliance, or technology quality in a regulated industry

Responsibilities

• Lead the global UDI program ensuring compliance with FDA, EU MDR and other international regulations
• Own UDI-related quality processes, procedures, and controls
• Partner with IT and digital teams for system design, validation, data integrity, and ongoing compliance
• Provide quality oversight for UDI data management including master data accuracy and change control
• Lead cross-functional collaboration across Regulatory Affairs, Supply Chain, Manufacturing, R&D and Commercial teams
• Support regulatory inspections, internal audits, and health authority interactions
• Monitor regulatory trends and translate requirements into scalable processes
• Drive continuous improvement to governance and compliance
• Coach and develop team members to strengthen UDI and quality capabilities

Skills

Analytical thinking

Regulatory compliance

Quality systems

UDI knowledge

Cross-functional leadership

Education

Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field

Master's degree (preferred)

Tools

ERP

PLM

Labeling systems

Job description

Job Function

Data Analytics & Computational Sciences

Job Sub Function

Multi-Family Data Analytics & Computational Sciences

Job Category

People Leader

All Job Posting Locations

Raritan, New Jersey, United States of America, Ringaskiddy, Cork, Ireland, West Chester, Pennsylvania, United States of America

Job Description

DePuy Synthes is recruiting for a Manager, Global UDI, located in Raynham, MA and Ringaskiddy, Ireland.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Raynham, MA (USA) - Requisition Number: 078355

Loughbeg, Ringaskiddy - Requisition Number: 081281

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Overview

The Manager, Global UDI is a key leadership role responsible for ensuring global compliance, governance, and execution of Unique Device Identification (UDI) requirements across DePuy Synthes’ orthopedic portfolio. This role partners closely with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data integrity, system readiness, and regulatory compliance across global markets.

This position offers the opportunity to lead a globally impactful compliance program that directly supports patient safety, product traceability, and regulatory readiness while shaping scalable, future‑ready UDI processes and systems.

Key Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.


• Own UDI‑related quality processes, procedures, and controls, ensuring alignment with standards.


• Partner with IT and digital teams to ensure UDI system design, validation, data integrity, and ongoing system compliance.


• Provide quality oversight for UDI data management, including master data accuracy, change control, and issue remediation.


• Lead cross‑functional collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams to ensure end‑to‑end UDI execution.


• Support and participate in regulatory inspections, internal audits, and health authority interactions related to UDI compliance.


• Monitor global regulatory trends and translate new or evolving UDI requirements into scalable business and quality processes.


• Drive continuous improvement initiatives to enhance UDI governance, efficiency, and compliance sustainability.


• Provide coaching and leadership to team members and stakeholders to strengthen UDI and quality capabilities across the organization.

Qualifications

Education

• Required: Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field.


• Preferred: Master’s degree in a scientific, technical, or business discipline.

Required

• 6–8 years of relevant experience in Quality Assurance, Regulatory Compliance, or Technology Quality within a regulated industry (medical devices strongly preferred).


• Demonstrated experience with UDI regulations and global regulatory frameworks (e.g., FDA, EU MDR).


• Strong knowledge of quality systems, data governance, and computerized system validation.


• Proven ability to lead cross‑functional, global initiatives in a matrixed organization.


• Experience supporting audits and regulatory inspections.


• Strong analytical, problem‑solving, and risk‑based decision‑making skills.


• Excellent written and verbal communication skills.

Preferred

• Experience working with enterprise systems supporting UDI and product data (e.g., ERP, PLM, labeling systems).


• Prior people‑leadership or matrix leadership experience.


• Experience within orthopedics or complex medical device portfolios.


• Familiarity with global supply chain and labeling processes.


• Change management or continuous improvement experience in regulated environments.

Other

• Language: English (additional languages a plus).


• Travel: Up to 10–20%, domestic and international.


• Certifications: ASQ, RAC, or equivalent quality/regulatory certifications preferred.

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.

Equal Opportunity Employer

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.

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.

#DePuySynthesCareers

Preferred Skills

Advanced Analytics, Change Management, Critical Thinking, Data Analysis, Data Privacy Standards, Data Quality, Data Reporting, Data Savvy, Data Science, Data Visualization, Developing Others, Digital Fluency, Inclusive Leadership, Leadership, Process Optimization, Relationship Building, Statistical Computing, Strategic Thinking

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00

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)).

This position is eligible to participate in the Company’s long-term incentive program.

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

Additional information can be found through the link below.

Co-Ops and Intern Positions: Please use the following language:

Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.

Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.

Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).

Positions Represented by CBA: Please use the following language:

This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.

The following link to general company benefits information MUST also be included in the posting: Please use the following language:

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits