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Manager, Global UDI Process & Governance

$102k - $177.1k

Johnson & Johnson Medical Devices

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.

Responsibilities

  • 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

Requirements

  • 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
Vacancy posted 9 days ago
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