Spec Regulatory UDI Operations

Job Summary

Job Description

MAJOR 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.

MINIMUM JOB REQUIREMENTS

Education

• Bachelor’s Degree in technical field or High School Diploma with extensive job experience.

Work Experience

• At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry.

Knowledge / Skills / Abilities

• 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.

PREFERRED JOB REQUIREMENTS

Education

• Bachelor’s degree in regulatory affairs or life sciences field.

Work Experience

• At least 3 years of experience in Quality or Regulatory Affairs for a regulated industry.

Knowledge / Skills / Abilities

• 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.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

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.

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. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

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.