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 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 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 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, 401(k) match

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Adobe InDesign proficiency required
  • FDA UDI GUDID database knowledge
  • EU MDR labeling requirements understanding
  • Change Control process execution

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Microsoft Office expertise
  • Vendor proof review experience

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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