Regulatory Labelling Associate

828

Palm Harbor, FL, United States
Label creation and control
Fda udi gudid database
Change control requests
Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements

Job Summary

  • Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.

Matching Summary

Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Skills & Requirements

Must-have

  • label creation and control
  • FDA UDI GUDID database
  • Change Control Requests
  • labeling compliance
  • Adobe InDesign proficiency

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • technical support for printing

Key Requirements

  • 3 years of experience
  • GMP, FDA, Change Control process
  • U.S. FDA UDI and EU MDR labeling requirements

Work Rights

Not specified

Tailored Resume

Cover Letter