Associate Regulatory UDI Operations
Core
Execute operational elements of the UDI program implementation and maintenance, ensuring compliance with US FDA regulations and other regulations.
Role type
Associate Regulatory UDI Operations Specialist
Builds
UDI compliant solutions for medical device labeling and regulatory submissions
Domain
Medical Devices / Regulatory Affairs
Required skills
UDI data collection and verification, FDA regulations knowledge, cross-functional collaboration, SOP maintenance, Quality Management System integration, process improvement
Preferred skills
Medical device labeling/UDI regulations expertise, FDA product codes and class structure knowledge, Quality Management Systems and GMP understanding
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook), GUDID, Medline data systems
Responsibilities
Collect and verify UDI data attributes from various sources; Assist in ensuring data accuracy between labels and master UDI data; Work with cross-functional teams to align regulatory submissions and labeling; Assist in implementing UDI compliant solutions; Support Quality Management System integration projects; Update and maintain procedures related to UDI/GUDID; Compile and review documentation for product development and manufacturing; Provide training on UDI/GUDID requirements; Propose process improvements for regulatory data submissions
Seniority
Junior, entry-level with supervision