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.
Performs upload and maintain the FDA UDI GUDID database and initiates/implements Change Control Requests pertaining to labeling updates.
Provides a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
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
FDA UDI GUDID database management
labeling document control
Adobe InDesign proficiency
Adobe Illustrator proficiency
Change Control Requests
Nice-to-have
continuous improvement focus
cross-functional collaboration
strong organizational skills
time management abilities
Key Requirements
3 years of GMP, FDA, Change Control process experience
General understanding of U.S. FDA UDI and EU MDR labeling requirements