Regulatory Labelling Associate

The Integer Group

Base wages; cash-based incentive program; comprehe...
Not specified (assumed to be in-office or hybrid based on the nature of the role).
3 years gmp experience
Fda udi and eu mdr knowledge
Adobe indesign proficiency
The Integer Group is seeking a Regulatory Labelling Associate who will prepare and manage product labels in compliance with FDA regulations and internal quality standards. The ideal candidate will have at least three years of experience in regulatory labeling, a strong attention to detail, and proficiency in Adobe software

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle.
  • Candidates must ensure labeling compliance with FDA regulations, company policies, and quality management systems.
  • The position offers a comprehensive benefits package including medical, dental, vision, and immediate 401(k) matching.

Matching Summary

Match Score: 85

The Integer Group is seeking a Regulatory Labelling Associate who will prepare and manage product labels in compliance with FDA regulations and internal quality standards. The ideal candidate will have at least three years of experience in regulatory labeling, a strong attention to detail, and proficiency in Adobe software.

Salary

Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, and 401(k) match

Skills & Requirements

Must-have

  • 3 years GMP experience
  • FDA UDI and EU MDR knowledge
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • Change Control process experience

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter