Manager, Global UDI
On-site · Raynham, Massachusetts, United States or Ringaskiddy, Munster, Ireland
Job Summary
Lead global UDI program to ensure compliance with FDA, EU MDR, and other international UDI regulations for DePuy Synthes’ orthopedic portfolio. Partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data integrity, system readiness, and regulatory compliance across global markets. Drive governance of UDI data, quality processes, change control, and issue remediation. Oversee cross-functional collaboration to ensure end-to-end UDI execution, participate in regulatory inspections, monitor regulatory trends, and translate requirements into scalable processes. Provide coaching and leadership to strengthen UDI and quality capabilities across the organization. Travel up to 10–20%.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field
- 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 with enterprise systems supporting UDI and product data (ERP, PLM, labeling)
- 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
- Travel: Up to 10–20% (domestic and international)
- Certifications: ASQ, RAC, or equivalent quality/regulatory certifications preferred
Desired Qualifications
- 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
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