Associate Regulatory UDI Operations

Medline Industries, LP; Northfield (MN); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a UDI Regulatory Coordinator to support implementation and ongoing maintenance of the UDI program. The role involves data collection, verification, and alignment with FDA regulations across multiple sites and teams.

You will collaborate with Regulatory Affairs, QA, Supply Chain, and R&D to ensure accurate labeling, GUDID submissions, and compliant documentation. Strong attention to detail and cross-functional communication are essential.

Qualifications

• Bachelor’s degree in life sciences.
• 1 year of experience in a Quality or Regulatory role for a regulated industry.
• Detail oriented with strong communication, organizational, analytical, and critical thinking skills.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Collect UDI data attributes from various sources.
• Verify and enter UDI data into databases per FDA regulations.
• Ensure data accuracy between labels and master UDI data.
• Collaborate with cross-functional teams across multiple sites for regulatory submissions and labeling/UDI database entries.
• Assist Regulatory Affairs and other teams in implementing UDI compliant solutions.
• Support QMS integration projects related to medical device labeling/UDI compliance.
• Update and maintain SOPs related to UDI/GUDID and other Quality documents.
• Coordinate timely review and implementation of these documents.
• Compile and review documentation for product development, manufacturing, and quality per UDI regulatory standards.
• Communicate status of deliverables to internal/external teams.
• Provide training on UDI/GUDID to various groups to ensure data integrity and understanding of requirements.
• Identify and propose process improvements to enhance data flow to GUDID and other regulatory submissions.

Education

Bachelor’s degree in life sciences

Tools

MS Office Suite (Word, Excel, PowerPoint, Outlook)

Job description

Job Summary

Job Summary This role will be responsible for supporting and executing the operational elements of the UDI program implementation and maintenance.

Job Description

MAJOR RESPONSIBILITIES

• Collect UDI data attributes from various sources
• Verify and enter UDI data into internal/external databases ensuring compliance with US FDA regulations and other regulations as needed
• Assist in ensuring data accuracy between labels and master UDI data, aligning with US FDA regulations and other regulations as needed
• Work closely with cross-functional teams located at multiple sites to support alignment between required information for regulatory submissions and labeling & UDI database entries, and providing regulatory input to project teams as needed
• Assist Regulatory Affairs members and other cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing, etc.,) in implementing UDI compliant solutions
• Support Quality Management System integration projects related to medical device labeling/ UDI compliance
• Assist in updating and maintaining procedures (SOPs) related to UDI/GUDID and other Quality documents
• Work collaboratively with various cross-functional teams to ensure timely review, approval, and implementation of these documents
• Assist in compiling and reviewing documentation and procedures related to product development, manufacturing, and quality in accordance with UDI regulatory standards and internal requirements
• Effectively communicate with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectations
• Assist in providing necessary training on UDI/GUDID to various groups to ensure data integrity, compliance, and understanding of the requirements
• Support the identification and proposal of process improvements to enhance flow and accuracy of Medline data to GUDID and other regulatory data submissions

MINIMUM JOB REQUIREMENTS

• Education: Bachelor’s degree (life sciences preferred)
• Work Experience: 1 year of experience in a Quality or Regulatory role for a regulated industry.
• Knowledge / Skills / Abilities: Manufacturing Practices, or willingness to learn through training and guided research.
• Detail oriented with strong communication, organizational, analytical, and critical thinking skills.
• Experience using time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.
• Self-starter with ability to work in team environment on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with some supervision.
• Relationship building and project management skills, to deliver results and meet deadlines.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

PREFERRED JOB REQUIREMENTS

• Education: Bachelor’s degree (life sciences preferred)
• Work Experience: Minimum of two (2) years of working experience and current knowledge of medical device labeling/UDI regulations, standards, and guidance
• Knowledge / Skills / Abilities: Work experience in 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 independent research.
• Detail oriented with strong communication, organizational, analytical, and critical thinking skills.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Self-starter with ability to work in team environment on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision.
• Relationship building and project management skills, to deliver results and meet deadlines.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Benefits

• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Salary

The anticipated salary range for this position: $67,000.00 - $101,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Equal Opportunity Statement

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Company Information

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

About Medline

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.