Regulatory Labelling Associate

Integer

Label creation and control
Fda udi gudid database
Change control process
Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle

Job Summary

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.
  • Collaborates with cross-functional teams to review product specifications evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.

Matching Summary

Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.

Skills & Requirements

Must-have

  • label creation and control
  • FDA UDI GUDID database
  • change control process
  • labeling translations management
  • vendor proof review
  • Adobe InDesign proficiency

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • strong attention to detail
  • organizational and time management

Key Requirements

  • 3 years of GMP, FDA, Change Control experience
  • Understanding of U.S. FDA UDI and EU MDR labeling
  • Microsoft Office experience

Work Rights

Not specified

Tailored Resume

Cover Letter