New · posted Nov 5
Medline · Medical Devices
Associate Regulatory UDI Operations
- Northfield, IL
- On-site
- Full-time
- Associate & Specialist
The role
This role will be responsible for supporting and executing the operational elements of the UDI program implementation and maintenance.
What you need
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).
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).
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:
$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.
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.
What you'll do
- 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.
Pay and benefits
$67,000 – $101,000 a year
Employer providedHealth insurance
Life and disability insurance
401(k) contributions
Paid time off
Bonus/incentive eligible
Continuing education & training
Where you'll work
Northfield, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Northfield, ILEqual opportunity, accessibility and legal noticesMedline's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $67,000 | — | $101,000 |
| All US (middle half) | $74,500 | $84,500 | $90,875 |
This role: Medline's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 36 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Medline's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- GMP and compliance6
- Regulatory submissions4
- Quality systems and risk3
- Data and digital systems3
- Lab testing and methods2
- Documentation and SOPs2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID databaseNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Medline on Regulatory Jobs
- 61
- Open roles
- 45
- Distinct roles
- 19
- Locations
By discipline
- Quality52 85%
- Regulatory8 13%
- Clinical1 2%
By level
- Associate & Specialist40 66%
- Senior & Principal15 25%
- Manager3 5%
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Associate Regulatory UDI Operations at Medline
Open until filled. $67K–$101K a year, employer provided.