Manager, Global UDI

Job Overview

Manager, Global UDI - leading this global compliance program across DePuy Synthes' orthopedic portfolio. The role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data integrity, system readiness, and regulatory compliance in all major markets.

Key Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable regulations.
• Own UDI related quality processes, procedures, and controls, ensuring alignment with industry standards.
• Partner with IT and digital teams to design, validate, and maintain UDI systems.
• Provide quality oversight for UDI data management, including master data accuracy, change control, and issue remediation.
• Collaborate with cross functional teams to execute UDI end to end.
• Support regulatory inspections, internal audits, and health authority interactions related to UDI compliance.
• Monitor regulatory trends and translate new UDI requirements into scalable business and quality processes.
• Drive continuous improvement initiatives to enhance UDI governance, efficiency, and compliance sustainability.
• Coach and lead team members and stakeholders to strengthen UDI and quality capabilities.

Qualifications

• Education: Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field. Master's degree preferred.
• Experience: 6-8 years in Quality Assurance, Regulatory Compliance, or Technology Quality - medical device experience strongly preferred.
• Demonstrated knowledge of UDI regulations (FDA, EU MDR) and global regulatory frameworks.
• 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.
• Analytical, problem solving, risk based decision making and excellent communication skills.
• Preferred: Experience with enterprise systems (ERP, PLM, labeling), people leadership, orthopedics portfolio, supply chain and labeling processes, change management or continuous improvement.
• Language: English required; additional languages are a plus.
• Travel: up to 10-20% domestic and international.

Certifications (Preferred)

• ASQ, RAC, or equivalent quality/regulatory certifications.

Benefits & Compensation

• Base salary: €70,100.00 - €121,210.00 (location dependent).
• Annual bonus target.
• Paid vacation days, parental leave (minimum 12 weeks), bereavement, caregiver, volunteer leave.
• Well being reimbursement and wellness programs.
• Service anniversary and recognition awards.
• Insurance plans (health, dental, vision) for employees and eligible dependents.

EEO Statement

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 law. We actively seek qualified candidates who are protected veterans and individuals with disabilities defined under VEVRAA and Section 503 of the Rehabilitation Act. We are committed to providing an inclusive interview process and accommodate applicants with disabilities upon request.