Regulatory Compliance Manager

Job Summary

Leading the regulatory compliance program, the full-time Manager, Regulatory Compliance will oversee audit readiness, regulatory intelligence, and post-market surveillance while ensuring alignment with global regulations and standards, with a preference for local candidates but consideration for remote work.

Key responsibilities

• Lead, develop, and mentor direct reports to enhance team capabilities and meet compliance needs
• Ensure the Quality Management System (QMS) remains aligned with applicable regulations and standards, collaborating with the Quality department for updates
• Manage regulatory intelligence and standards monitoring, assessing business impacts of new regulations and coordinating necessary changes

Required qualifications

• Bachelor's degree in life science or engineering discipline or equivalent experience
• 2+ years of medical device experience and 8+ years of regulatory compliance experience
• 5+ years of demonstrated leadership experience
• Knowledge of FDA regulations, EU MDR, and related global regulations
• Experience with corporate compliance and trade compliance programs