Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle
Job Summary
Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.
Performs upload and maintain the FDA UDI GUDID database and initiates and/or implements Change Control Requests pertaining to labeling updates.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including a comprehensive benefits package with immediate eligibility.
Matching Summary
Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.
Skills & Requirements
Must-have
label creation and control
FDA UDI GUDID database
change control requests
labeling translations management
vendor proof review
Nice-to-have
continuous improvement focus
cross-functional collaboration
customer success focus
respectful interaction
Key Requirements
3 years of GMP, FDA, Change Control process experience
General understanding of U.S. FDA UDI and EU MDR labeling requirements