UDI Compliance Operations Specialist

2 weeks ago


Northbrook, Illinois, United States Medix™ Full time

Key Responsibilities:

  • Gather UDI data attributes from diverse sources; validate and input UDI information into both internal and external databases, ensuring adherence to US FDA regulations and other applicable standards.
  • Maintain data integrity between product labels and master UDI data, in compliance with regulatory mandates.
  • Collaborate with cross-departmental teams across multiple locations to ensure consistency between regulatory submissions, labeling, and UDI database entries.
  • Provide regulatory insights to project teams as necessary.
  • Assist Regulatory Affairs and various teams (e.g., Supply Chain, R&D, QA, Marketing) in executing UDI-compliant strategies.
  • Support integration projects related to Quality Management Systems concerning medical device labeling and UDI compliance.
  • Revise and uphold procedures (SOPs) associated with UDI/GUDID and other Quality documentation.
  • Work collaboratively with cross-functional teams to guarantee timely review, approval, and implementation of these documents.
  • Compile and assess documentation and procedures pertinent to product development, manufacturing, and quality in line with UDI regulatory standards.
  • Effectively communicate with internal and external teams or clients regarding the status of deliverables to ensure timely task completion.
  • Provide essential training on UDI/GUDID to various groups to uphold data integrity, compliance, and comprehension of requirements.
  • Support the identification and suggestion of process enhancements to improve the flow and accuracy of Medline data to GUDID and other regulatory submissions.

Essential Qualifications:

Education:

  • Bachelor's degree (preferably in Life Sciences, though not mandatory)

Professional Experience:

  • Minimum of 1 year in a Quality or Regulatory role within a regulated sector.

Skills and Competencies:

  • Familiarity with Manufacturing Practices or a willingness to learn through training and guided research.
  • Detail-oriented with excellent communication, organizational, analytical, and critical thinking abilities.
  • Proficient in time management, prioritization, and organization to meet project deadlines.
  • Self-motivated individual capable of collaborating in a team environment on projects of varied scope with some supervision.
  • Strong relationship-building and project management capabilities to achieve results and meet deadlines.
  • Experience with MS Office Suite applications (Word, Excel, PowerPoint, Outlook).


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