Regulatory Labelling Associate

Integer

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 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 perform uploads and maintain the FDA UDI GUDID database and initiate change control requests for labeling updates.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.

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

  • 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 experience

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • General understanding of US FDA UDI requirements
  • EU MDR labeling requirements knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter