Illinois Licensed Regulatory Compliance Manager

Job Summary

A company is looking for a Manager Regulatory Trade Compliance.

Key Responsibilities

• Ensure compliant importation of medical devices and kits into the U.S. and oversee FDA import data accuracy
• Develop standardized processes and maintain SOPs related to FDA import compliance
• Act as the primary contact for FDA detentions, leading root cause analysis and corrective actions

Required Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field
• Minimum 5 years of experience in the FDA-regulated industry
• Experience managing import compliance for medical kits or convenience kits
• Demonstrated experience creating and implementing business processes and governance controls
• Equivalent combination of education and experience will be considered