Global UDI

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.comAs 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: Project/Program Management GroupJob Sub Function: Project/Program ManagementJob Category:ProfessionalAll Job Posting Locations:Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of AmericaJob Description:DePuy Synthes is recruiting for a(n) Global UDI located in Raynham, MassachusettsThe Global UDI role plays a critical part in ensuring DePuy Synthes’ global compliance with Unique Device Identification (UDI) regulatory requirements through robust quality oversight of enabling technologies, systems, and processes. This position partners cross‑functionally with Regulatory Affairs, IT, Supply Chain, and Manufacturing to ensure UDI data accuracy, system validation, and sustained compliance across global markets. The role offers high visibility, global impact, and the opportunity to influence enterprise‑level quality and digital transformation initiatives supporting patient safety and regulatory excellence.Key Responsibilities Provide oversight for global UDI technology platforms, data flows, and supporting systems to ensure regulatory compliance and data integrity. Support development, implementation, and maintenance of UDI‑related quality processes, procedures, and controls across the product lifecycle. Partner with IT and business stakeholders to ensure UDI systems are validated, maintained, and compliant with applicable quality system regulations. Review and approve UDI‑related documentation, including system validation deliverables, change controls, risk assessments, and procedural updates. Monitor and assess UDI data accuracy, completeness, and timeliness across internal systems and external regulatory databases. Support internal and external audits, inspections, and health authority interactions related to UDI and supporting technologies. Identify quality risks, trends, and improvement opportunities related to UDI processes and digital solutions; drive corrective and preventive actions. Provide quality guidance and training to cross‑functional partners on UDI requirements, quality standards, and system controls. Qualifications Education Required: Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline. Preferred: Advanced degree in Quality, Regulatory, or a technical field. Experience and Skills Required: Typically 4–8 years of experience in Quality Assurance, Quality Systems, or Regulatory‑adjacent roles within medical devices, pharmaceuticals, or regulated industries. Experience supporting validated systems and technology platforms in a regulated environment. Working knowledge of global UDI regulations (e.g., FDA, EU MDR) and quality system requirements. Experience with change control, risk management, and documentation review within a quality framework. Demonstrated ability to analyze quality data, identify trends, and drive continuous improvement. Preferred: Experience with UDI databases, labeling systems, or enterprise data management platforms. Familiarity with computer system validation (CSV) and digital quality controls. Experience supporting regulatory inspections or audits related to data integrity or digital systems. Knowledge of Lean, Six Sigma, or continuous improvement methodologies. Experience working in a global or matrixed organization. Strong collaboration skills with the ability to work effectively across global, cross‑functional teams. Other: Language: English proficiency required. Travel: Up to ~10–15%, domestic and occasional international. Certifications: ASQ certifications (e.g., CQA, CQE) or similar quality certifications preferred. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit 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.Required Skills:Preferred Skills:Agility Jumps, Analytics Insights, Business Alignment, Business Behavior, Collaboration Tools, Communication, Cost-Benefit Analysis (CBA), Data Analysis, Monitoring, Evaluation, and Learning (MEL), Problem Solving, Process Oriented, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Support, Statement of Work (SOW), Time ManagementThe anticipated base pay range for this position is :110,500.00 USD AnnualAdditional 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: - Raynham, Massachusetts, United States of America; West Chester, Pennsylvania, United States of America; Palm Beach Gardens, Florida, United States of America; Warsaw, Indiana, United States of America; Raritan, New Jersey, United States of AmericaType: Full time