Base wages; cash-based incentive program; comprehe...
Fda udi gudid database management
Adobe indesign and illustrator proficiency
Gmp and fda regulatory knowledge
The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle
Job Summary
The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.
Candidates must possess strong proficiency with Adobe InDesign and Illustrator to ensure formatting and technical construction conform to guidelines.
The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and immediate eligibility for various insurance programs.
Matching Summary
The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.
Salary
Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, 401(k) match
Skills & Requirements
Must-have
FDA UDI GUDID database management
Adobe InDesign and Illustrator proficiency
GMP and FDA regulatory knowledge
Change Control process experience
Label validation plan execution
Nice-to-have
EU MDR labeling requirements knowledge
Cross-functional team collaboration skills
Continuous improvement mindset
Vendor proof approval experience
Strong attention to detail
Key Requirements
Minimum 3 years of GMP and FDA experience
General understanding of US FDA UDI and EU MDR requirements