Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Adobe indesign proficiency required
Fda udi gudid database management
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations
Job Summary
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.
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, 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 FDA regulations.
Salary
Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, disability, life insurance, and 401(k) matching
Skills & Requirements
Must-have
3 years GMP and FDA experience
Adobe InDesign proficiency required
FDA UDI GUDID database management
Change Control process knowledge
EU MDR labeling requirements understanding
Nice-to-have
Strong attention to detail
Cross-functional team collaboration
Continuous improvement mindset
Vendor proof review skills
Label validation plan support
Key Requirements
Minimum 3 years of GMP and FDA experience
General understanding of US FDA UDI and EU MDR requirements
Proficiency with Microsoft Office and label creation software