Base wages; cash-based incentive program; comprehe...
3+ years gmp and fda experience
Proficiency with adobe indesign
Knowledge of fda udi and eu mdr
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while ensuring strict adherence to FDA regulations
Job Summary
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while ensuring strict adherence to FDA regulations.
Candidates must possess strong proficiency with Adobe InDesign and have a general understanding of U.S. FDA UDI and EU MDR labeling requirements.
The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays per year.
Matching Summary
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while ensuring strict adherence to FDA regulations.
Salary
Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, 401(k) match
Skills & Requirements
Must-have
3+ years GMP and FDA experience
Proficiency with Adobe InDesign
Knowledge of FDA UDI and EU MDR
Experience with Change Control processes
Strong attention to detail
Nice-to-have
Adobe Illustrator proficiency
Label creation software knowledge
Cross-functional collaboration skills
Continuous improvement mindset
Key Requirements
Minimum 3 years of GMP and FDA experience
General understanding of EU MDR labeling requirements