Senior Software Engineer, Bioinformatics

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