Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Proficiency with adobe indesign
Knowledge of u.s. fda udi requirements
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.
  • Employees will perform upload and maintenance of the FDA UDI GUDID database and initiate Change Control Requests for labeling updates.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays.

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) match

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Proficiency with Adobe InDesign
  • Knowledge of U.S. FDA UDI requirements
  • Experience with Change Control processes
  • EU MDR labeling requirements knowledge

Nice-to-have

  • Strong attention to detail
  • Excellent organizational abilities
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Adobe Illustrator proficiency

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • General understanding of EU MDR labeling
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

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