Associate Regulatory UDI Operations

Medline Industries, LP • Northfield, IL

6d • $67,000 - $101,000

About The Position

This role supports and executes the operational elements of implementing and maintaining the UDI program. The associate collects, verifies, and enters UDI data from various sources into internal and external databases, helping ensure compliance with US FDA and other applicable regulations. The role also helps align label information with master UDI data and supports consistency between regulatory submissions, labeling, and UDI database entries.

Working with Regulatory Affairs and cross-functional teams—including Supply Chain, R&D, QA, and Marketing—the associate helps implement UDI-compliant solutions, supports Quality Management System integration projects, and assists with maintaining related procedures and quality documents. The role contributes to documentation review, training, communication about deliverables, and process improvements that enhance the accuracy and flow of Medline data to GUDID and other regulatory submissions.

Medline offers a competitive total rewards package, continuing education and training, and career potential in a growing worldwide organization. The anticipated annual salary range is $67,000–$101,000; actual pay varies based on location, education, experience, skills, and abilities. The role is bonus and/or incentive eligible. Benefits for employees working an average of 30 or more hours per week include health insurance, life and disability coverage, 401(k) contributions, and paid time off. Employees working fewer than 30 hours per week receive 401(k) contributions, paid time off, and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp. Medline is an equal opportunity employer and emphasizes belonging, inclusion, and career growth.

Requirements

• Bachelor’s degree; life sciences preferred.
• At least 1 year of experience in a Quality or Regulatory role in a regulated industry.
• Detail-oriented, with strong communication, organizational, analytical, and critical-thinking skills.
• Ability to prioritize, organize, and track details to meet deadlines across multiple projects.
• Self-starter able to work in a team environment on projects of diverse scope, evaluating multiple factors with some supervision.
• Relationship-building and project-management skills to deliver results and meet deadlines.
• Experience using Microsoft Office Suite products, including Word, Excel, PowerPoint, and Outlook.

Nice To Haves

• Bachelor’s degree in life sciences.
• At least 2 years of work experience and current knowledge of medical device labeling and UDI regulations, standards, and guidance.
• Experience evaluating information to determine compliance with standards, laws, and regulations.
• Knowledge and understanding of FDA product codes and product class structure, Quality Management Systems, and Good Manufacturing Practices, or willingness to learn through training and guided or independent research.
• Ability to work on projects of diverse scope and evaluate multiple factors with minimal supervision.

Responsibilities

• Collect UDI data attributes from various sources; verify and enter UDI data into internal and external databases in accordance with US FDA and other applicable regulations.
• Help ensure data accuracy between product labels and master UDI data.
• Coordinate with cross-functional teams at multiple sites to align regulatory submission information with labeling and UDI database entries, and provide regulatory input to project teams as needed.
• Assist Regulatory Affairs and cross-functional teams, including Supply Chain, R&D, QA, and Marketing, with implementing UDI-compliant solutions.
• Support Quality Management System integration projects related to medical device labeling and UDI compliance.
• Assist in updating and maintaining UDI/GUDID procedures, SOPs, and other quality documents, coordinating their timely review, approval, and implementation.
• Assist in compiling and reviewing product development, manufacturing, and quality documentation and procedures in accordance with UDI regulatory standards and internal requirements.
• Communicate deliverable status to internal and external teams or clients to support timely and satisfactory completion of tasks.
• Assist with providing UDI/GUDID training to support data integrity, compliance, and understanding of requirements.
• Support identifying and proposing process improvements to enhance the flow and accuracy of Medline data to GUDID and other regulatory data submissions.

Benefits

• Health insurance
• Life insurance
• Disability coverage
• 401(k) contributions
• Paid time off
• Continuing education and training
• Bonus and/or incentive eligibility
• Employee Assistance Program (for employees working fewer than 30 hours per week)
• Employee Resource Groups (for employees working fewer than 30 hours per week)
• Employee Service Corp (for employees working fewer than 30 hours per week)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level