Regulatory Labelling Associate

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Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Adobe indesign proficiency required
Fda udi gudid database management
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.
  • 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 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 management
  • Change Control process knowledge
  • EU MDR labeling requirements

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Vendor proof approval experience

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • Knowledge of US FDA UDI and EU MDR requirements
  • Proficiency in Change Control processes

Work Rights

Not specified

Tailored Resume

Cover Letter