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 throughout the product life-cycle while adhering to strict safety and quality requirements
Job Summary
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to strict safety and quality requirements.
Candidates must possess strong proficiency with Adobe InDesign and Illustrator to ensure formatting and technical construction conform to established guidelines.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.
Matching Summary
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to strict safety and quality requirements.
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
Continuous improvement mindset
Vendor proof approval skills
Strong attention to detail
Key Requirements
Minimum three years of GMP and FDA experience
General understanding of US FDA UDI and EU MDR requirements