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Regulatory UDI Operations Specialist

3 months ago

Northbrook, United States Medix™ Full time

Major Responsibilities:

  • Collect UDI data attributes from various sources; verify and enter UDI data into internal/external databases, ensuring compliance with US FDA regulations and other relevant regulations.
  • Ensure data accuracy between labels and master UDI data, aligning with regulatory requirements.
  • Collaborate with cross-functional teams at multiple sites to support alignment between regulatory submissions, labeling, and UDI database entries.
  • Provide regulatory input to project teams as needed.
  • Assist Regulatory Affairs and cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing) in implementing UDI-compliant solutions.
  • Support Quality Management System integration projects related to medical device labeling and UDI compliance.
  • Update and maintain procedures (SOPs) related to UDI/GUDID and other Quality documents.
  • Work with cross-functional teams to ensure timely review, approval, and implementation of these documents.
  • Compile and review documentation and procedures related to product development, manufacturing, and quality in accordance with UDI regulatory standards.
  • Communicate effectively with internal and external teams or clients regarding the status of deliverables to ensure timely completion of tasks.
  • Provide necessary training on UDI/GUDID to various groups to ensure data integrity, compliance, and understanding of requirements.
  • Support the identification and proposal of process improvements to enhance the flow and accuracy of Medline data to GUDID and other regulatory data submissions.


Minimum Job Requirements:


Education:

  • Bachelor’s degree (Life sciences preferred, not required)


Work Experience:

  • 1 year of experience in a Quality or Regulatory role within a regulated industry.


Knowledge / Skills / Abilities:

  • Understanding of Manufacturing Practices or willingness to learn through training and guided research.
  • Detail-oriented with strong communication, organizational, analytical, and critical thinking skills.
  • Proficient in time management, prioritization, and organization to meet project deadlines.
  • Self-starter capable of working in a team environment on projects of diverse scope with some supervision.
  • Strong relationship-building and project management skills to deliver results and meet deadlines.
  • Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).