Manager, Global UDI Process & Governance
Johnson & Johnson · Raritan, NJ +2 more
QualityFull-time$102k–$177kCompany career page
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Role summary
Johnson & Johnson MedTech seeks a Manager for Global UDI Process and Governance to lead compliance and execution of Unique Device Identification requirements across the medical device portfolio. The role encompasses regulatory adherence, data governance, cross-functional collaboration, and continuous improvement initiatives across global markets.
What they're looking for
- Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field
- 6–8 years of Quality Assurance, Regulatory Compliance, or process engineering in regulated medical device industry
- Demonstrated expertise with UDI regulations and global frameworks including FDA and EU MDR
- Understanding of quality systems, data governance, and computerized system validation
- Proven ability to lead cross-functional initiatives in matrixed organizations
- Experience supporting regulatory audits and inspections
- Strong analytical, problem-solving, and risk-based decision-making capabilities
What you'll be doing
- Lead and govern global UDI program ensuring compliance with FDA, EU MDR, and international regulations
- Own UDI processes, procedures, and controls aligned with quality and regulatory standards
- Partner with technology teams to establish capabilities for executing UDI-related processes
- Lead cross-functional collaboration with Regulatory, Supply Chain, Manufacturing, R&D, and Commercial teams
- Monitor regulatory trends and translate evolving UDI requirements into scalable business processes
Privacy & handoff
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