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.
The total rewards program includes base wages, a cash-based incentive program, comprehensive benefits with immediate eligibility, and 401(k) plan with company matching.
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
Adobe InDesign proficiency
Adobe Illustrator proficiency
Change Control process
Labeling translations management
Nice-to-have
Continuous improvement focus
Cross-functional collaboration
Customer success focus
Respectful interaction
Key Requirements
3 years of GMP, FDA, Change Control experience
Understanding of U.S. FDA UDI and EU MDR labeling requirements