Global UDI

Johnson & Johnson Innovative Medicine • Warsaw, IN

1d • $79,000 - $142,000 • Onsite

About The Position

The 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.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline.
• 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.
• English proficiency required.

Nice To Haves

• Advanced degree in Quality, Regulatory, or a technical field.
• 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.
• ASQ certifications (e.g., CQA, CQE) or similar quality certifications preferred.

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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level