Associate, Regulatory Affairs (Medical Devices)

📋 Description

• Manage and deliver regulatory docs for global registrations
• Coordinate medical device submissions and respond to queries
• Evaluate docs for accuracy and consistency of submissions
• Prepare/review letters of authorization and registration letters
• Coordinate legalization, notarization, and apostille
• Submit and manage US FDA Certificates of Foreign Government (CFGs)

🎯 Requirements

• Bachelor's degree in Life Sciences or regulatory field
• 1+ year Regulatory Affairs in medical devices (registrations/submissions)
• Knowledge of EU MDD/MDR, US FDA QSR, ISO 13485
• Proficiency with Microsoft Word, Excel, PowerPoint
• Strong GDP understanding and good documentation practices
• Excellent English communication, written and verbal