Spec Regulatory UDI Operations

Medline•Northfield, MN

About The Position

Leads day-to-day UDI operations by managing UDI data integrity, driving process consistency, and coordinating cross-functional efforts to ensure ongoing compliance with US FDA GUDID requirements. Serves as the primary point of contact for UDI-related processes and data accuracy within the organization.

Requirements

Bachelor’s Degree in technical field or High School Diploma with extensive job experience.
At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry.
Proficient in MS Office Suite products (Word, Excel, PowerPoint, Outlook).
Proven experience leading projects and driving process improvements through critical thinking and problem solving.
Ability to review, evaluate, and reconcile complex data and documentation with high attention to detail.
Experience interpreting and evaluating compliance with standards, laws, and regulations.

Nice To Haves

Bachelor’s degree in regulatory affairs or life sciences field.
At least 3 years of experience in Quality or Regulatory Affairs for a regulated industry.
Working knowledge of FDA product codes, product class structure, Quality Management Systems, and Good Manufacturing Practices.
Strong communication and relationship-building skills; demonstrated project management, critical thinking, and problem-solving abilities to deliver results and meet deadlines.
Ability to assess regulatory risk and recommend mitigation strategies.

Responsibilities

Lead and maintain UDI data across internal and external regulatory databases.
Ensure and monitor consistency between product labeling and master UDI data through regular audits and updates.
Coordinate and lead cross-functional teams to implement, maintain, and improve UDI-compliant processes.
Oversee documentation reviews and verification activities to ensure product information meets UDI compliance requirements.
Lead or support Quality Management System (QMS) integration activities related to labeling and UDI data management.
Manage communications with internal and external stakeholders to align project deliverables, timelines, and regulatory submissions.
Support and deliver training efforts to promote understanding of UDI/GUDID requirements across departments.
Develop, revise, and maintain SOPs and work instructions related to UDI and regulatory data management.
Ensure data accuracy and integrity through effective use of tools, controls, and verification practices.
Provide guidance and support to Associate-level staff and other team members on UDI data practices and system use.