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.
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
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 management
Change Control process
Adobe InDesign proficiency
Adobe Illustrator proficiency
Nice-to-have
Continuous improvement focus
Cross-functional collaboration
Customer success focus
Respectful interaction
Key Requirements
Minimum 3 years GMP, FDA, Change Control experience
General understanding of U.S. FDA UDI and EU MDR labeling
Experience with Microsoft Office
Strong organizational and time management abilities