Associate Regulatory UDI Operations

Medline • Northfield, MN

5d

About The Position

This role supports and executes operational aspects of implementing and maintaining the UDI program. The associate collects, verifies, and enters UDI data into internal and external databases, ensuring accuracy and alignment with product labels and applicable regulatory requirements, including US FDA regulations.

The position collaborates with cross-functional teams across multiple sites, including Regulatory Affairs, Supply Chain, R&D, Quality Assurance, and Marketing. It supports alignment among regulatory submissions, labeling, and UDI database entries; assists with UDI-compliant solutions and Quality Management System integration projects; and helps maintain procedures and documentation related to UDI/GUDID, product development, manufacturing, and quality.

The associate communicates deliverable status to internal and external stakeholders, supports UDI/GUDID training, and helps identify process improvements to enhance the flow and accuracy of data submitted to GUDID and other regulatory systems. The role requires strong organization, attention to detail, communication, analytical thinking, project coordination, and the ability to manage multiple deadlines with some supervision.

Requirements

• Bachelor’s degree; life sciences preferred.
• At least 1 year of experience in a Quality or Regulatory role in a regulated industry.
• Knowledge of Good Manufacturing Practices, or willingness to learn through training and guided research.
• Strong attention to detail, 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 and evaluate 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/UDI regulations, standards, and guidance.
• Experience evaluating information to determine compliance with standards, laws, and regulations.
• Knowledge of FDA product codes and product class structure, Quality Management Systems, and Good Manufacturing Practices, or willingness to learn through training and 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 and verify and enter UDI data into internal and external databases in compliance with applicable regulations.
• Help ensure data accuracy between product labels and master UDI data.
• Work 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 other teams, including Supply Chain, R&D, Quality Assurance, and Marketing, in 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, standard operating procedures, and other Quality documents.
• Collaborate with cross-functional teams to support timely review, approval, and implementation of documents.
• Assist in compiling and reviewing product development, manufacturing, and quality documentation and procedures in accordance with UDI standards and internal requirements.
• Communicate the status of deliverables to internal and external teams or clients to support timely and satisfactory completion of work.
• Assist with UDI/GUDID training for various groups to support data integrity, compliance, and understanding of requirements.
• Support identification and proposal of process improvements to enhance the flow and accuracy of company data to GUDID and other regulatory submissions.

Benefits

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

What This Job Offers

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