Johnson & Johnson

Manager, Global UDI

Johnson & Johnson$117K — $201K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field required; Master’s degree preferred.
  • 6–8 years of experience in Quality Assurance, Regulatory Compliance, or Technology Quality within a regulated industry, preferably medical devices.
  • Familiarity with UDI regulations and global regulatory frameworks (e.g., FDA, EU MDR).
  • Strong knowledge of quality systems, data governance, and computerized system validation.
  • Proven leadership in cross-functional, global initiatives in a matrix organization.

Responsibilities

  • Lead the global UDI program to ensure compliance with U.S. and international regulations.
  • Manage UDI-related quality processes and controls for alignment with standards.
  • Collaborate with IT teams to ensure UDI system validation and data integrity.
  • Oversee UDI data management for accuracy and change control processes.
  • Facilitate cross-function collaborations for end-to-end UDI execution.
  • Support regulatory inspections and audits related to UDI compliance.
  • Monitor evolving global regulatory trends to adapt business processes.

Benefits

  • Opportunity to lead impactful global compliance programs.
  • Work in a mission-driven organization emphasizing patient safety and product traceability.
  • Access to a diverse range of career advancement opportunities within a global company.
  • Retention of existing benefits post-separation into a standalone company.
  • Structured support for employee wellness and work-life balance.
Full 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 leadershiprole responsiblefor 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‑readyUDI processes and systems.

Key Responsibilities

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

  • OwnUDI‑relatedquality 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, andissueremediation.

  • Leadcross‑functionalcollaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams to ensure end‑to‑endUDI execution.

  • Support andparticipatein 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, ora relatedfield.

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

Experience and Skills

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 leadcross‑functional, global initiatives in a matrixed organization.

  • Experience supporting audits and regulatory inspections.

  • Strong analytical,problem‑solving, andrisk‑baseddecision‑makingskills.

  • Excellent written and verbal communication skills.

Preferred:

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

  • Priorpeople‑leadershipor 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 (additionallanguages 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.

#LI-Hybrid 

#DePuySynthesCareers 
 

Required Skills:

 

 

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.



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



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://ww

About Johnson & Johnson

Scio Diamond creates single-crystal Type IIa diamonds for the jewelry market and for industrial applications. It employs a patent-protected chemical vapor deposition (CVD) process in a precisely controlled laboratory setting to produce diamonds. It was founded in 2009 and is headquartered in Greenville, South Carolina.

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Learn more about Johnson & Johnson
Size
141,700 employees
Market Cap
$462.7 billion
Industry
Net Income
$14.7 billion
Founded
1886
5 Year Trend
+5.5%
Revenue
$82.5 billion
NASDAQ

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