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, incentive program, overtime pay, and a comprehensive benefits package with immediate eligibility for medical, dental, vision, and 401(k) 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
FDA regulations
label creation software
Adobe InDesign
Adobe Illustrator
revision control
label validation
Nice-to-have
continuous improvement
cross-functional collaboration
customer success focus
respectful interaction
Key Requirements
3 years of GMP, FDA, Change Control experience
General understanding of U.S. FDA UDI and EU MDR labeling requirements