Labeling Specialist

Marketplacemall

**
Labeling and instructions for use preparation
Revision control and tracking
Fda udi gudid database management
** Marketplacemall is seeking a Labeling Specialist with a strong background in FDA regulations and labeling processes. The ideal candidate will have at least three years of experience in a regulated environment, proficiency in Adobe software, and a keen attention to detail. The position offers a comprehensive benefits package and a supportive work culture centered around collaboration and innovation. **

Job Summary

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.
  • Uploads and maintains the FDA UDI GUDID database, initiates and implements Change Control Requests pertaining to labeling updates, and collaborates with cross-functional teams.
  • Offers a comprehensive total rewards program including base wages, incentive programs, comprehensive benefits with immediate eligibility, and 401(k) with company matching.

Matching Summary

Match Score: 75

** Marketplacemall is seeking a Labeling Specialist with a strong background in FDA regulations and labeling processes. The ideal candidate will have at least three years of experience in a regulated environment, proficiency in Adobe software, and a keen attention to detail. The position offers a comprehensive benefits package and a supportive work culture centered around collaboration and innovation. **

Skills & Requirements

Must-have

  • Labeling and Instructions for Use preparation
  • Revision control and tracking
  • FDA UDI GUDID database management
  • Change Control Request initiation
  • Cross-functional team collaboration
  • Adobe InDesign and Illustrator proficiency

Nice-to-have

  • Continuous improvement mindset
  • Respectful interaction with others
  • Open and honest communication
  • Focus on customer success

Key Requirements

  • Minimum 3 years of GMP, FDA, Change Control process experience
  • General understanding of U.S. FDA UDI and EU MDR labeling requirements
  • Proficiency with Microsoft Office
  • Strong organizational and time management abilities

Work Rights

Not specified

Tailored Resume

Cover Letter