Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Adobe indesign proficiency required
Fda udi gudid database knowledge
The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.
  • Candidates must perform uploads and maintain the FDA UDI GUDID database while ensuring all labeling is compliant with regulatory standards.
  • 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 according to established procedures throughout the product life-cycle.

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
  • Adobe InDesign proficiency required
  • FDA UDI GUDID database knowledge
  • Change Control process expertise
  • EU MDR labeling requirements understanding

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Microsoft Office experience
  • Adobe Illustrator knowledge

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of US FDA UDI and EU MDR
  • Proficiency with Adobe InDesign and Illustrator

Work Rights

Not specified

Tailored Resume

Cover Letter