Global UDI
$79,000–$142,000 year
On-site · Palm Beach Gardens, Florida, United States or Raritan, New Jersey, United States
Job Summary
Global UDI role at Johnson & Johnson (DePuy Synthes) responsible for global UDI technology platforms, data flows, and systems to ensure regulatory compliance and data integrity. Partners with Regulatory Affairs, IT, Supply Chain, and Manufacturing to validate systems, maintain quality controls, and support audits/inspections. Develops and maintains UDI-related quality processes across the product lifecycle, reviews documentation (system validation deliverables, change controls, risk assessments, procedures), identifies risks, drives CAPA, and provides training on UDI requirements and quality standards. Travel up to ~10–15% to support global regulatory readiness and quality initiatives.
Required Qualifications
- 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
- 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 cross-functional teams
- English proficiency and travel up to 10–15%
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