Job Summary

• Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.
• Uploads and maintains the FDA UDI GUDID database, initiates and implements Change Control Requests pertaining to labeling updates.
• Collaborates with cross-functional teams to review product specifications, evaluate product characteristics, and ensure labeling is compliant with regulatory requirements.

Matching Summary

Skills & Requirements

Key Requirements

• Minimum 3 years experience
• GMP, FDA, Change Control process
• U.S. FDA UDI and EU MDR labeling knowledge

Work Rights