Regulatory Affairs Specialist - UDI Labeling - 239365 Job at Medix™, Glenview, IL

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  • Medix™
  • Glenview, IL

Job Description

Regulatory UDI Operations Specialist

We are seeking a Regulatory UDI Operations Specialist to support UDI program implementation and compliance with FDA and global regulations in the medical device industry. This role collaborates with Regulatory Affairs, Supply Chain, R&D, QA, and Marketing to ensure accurate UDI data management.

Key Responsibilities:

  • Collect, verify, and enter UDI data into internal/external databases.
  • Ensure data accuracy between labels and master UDI data.
  • Assist in implementing UDI-compliant solutions and updating SOPs.
  • Support process improvements for regulatory data accuracy.
  • Provide training on UDI/GUDID requirements.

Qualifications:

  • 1+ years of UDI experience in medical devices.
  • Experience with ERP systems (SAP/Oracle) .
  • Bachelors degree in life science or related field.
  • Strong attention to detail, communication, and organizational skills.

Join a growing team in the medical device industry today!

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