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 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 a minimum of three years of experience in GMP, FDA regulations, and Change Control processes.
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
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
Microsoft Office expertise
Key Requirements
Minimum 3 years of GMP and FDA experience
General understanding of US FDA UDI requirements
General understanding of EU MDR labeling requirements