Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
Fda udi gudid database management
Adobe indesign and illustrator proficiency
Gmp and fda regulatory knowledge
The role requires preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role requires 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 requires 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, 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
  • Strong attention to detail
  • Cross-functional team collaboration
  • Continuous improvement mindset
  • Vendor proof approval skills

Key Requirements

  • Minimum three years of GMP and FDA experience
  • General understanding of US FDA UDI and EU MDR requirements
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter