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.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: Project/Program Management Group Job Sub Function: Project/Program Management Job Category: Professional All 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 America Job Description: DePuy Synthes is recruiting for a(n) Global UDI located in Raynham, Massachusetts The Global UDI role plays a critical part in ens u ring 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. </s