Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle
Job Summary
Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.
Upload and maintain the FDA UDI GUDID database, initiate and/or implement Change Control Requests pertaining to labeling updates.
Collaborates with cross-functional teams to review product specifications evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.
Matching Summary
Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.
Skills & Requirements
Must-have
Labeling document control
FDA UDI GUDID database
Change Control Requests
Adobe InDesign proficiency
Adobe Illustrator proficiency
Nice-to-have
Continuous improvement focus
Cross-functional collaboration
Attention to detail
Organizational skills
Time management abilities
Key Requirements
3 years of GMP, FDA, Change Control process
Knowledge of U.S. FDA UDI and EU MDR labeling requirements