New · posted Oct 15
Medline · Medical Devices
Regulatory Reporting Specialist
- Mundelein, IL
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Regulatory Reporting Specialist is responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.
What you need
Education & Work Experience
Bachelor’s degree in a relevant field AND 1+ year of experience in complaint handling, MDR evaluation, post‑market surveillance, regulatory affairs, or other relevant experience within a regulated industry.
Knowledge / Skills / Abilities
- Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).
- Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.
- Strong analytical and critical‑thinking skills with the ability to apply updated decision logic consistently.
- Effective cross‑functional communication and collaboration skills.
- Ability to manage multiple priorities and meet strict remediation timelines.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint).
Preferred job requirementsnice to have
- 2+ years of experience supporting complaint remediation, MDR reporting, or similar activities within a regulated medical device, pharmaceutical, or healthcare environment.
- Experience working in environments requiring large‑scale retrospective reviews or high‑volume documentation processing.
- Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.
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
- Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.
- Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.
- Work cross‑functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.
- Prepare and submit MDRs through the FDA’s electronic submission portal (eMDR) for newly identified reportable events.
- Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.
Pay and benefits
$67,000 – $101,000 a year
Employer providedHealth insurance
Life and disability insurance
401(k) contributions
Paid time off
Continuing education & training
Bonus/incentive eligible
Where you'll work
Mundelein, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Mundelein, 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 · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US27 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $67,000 | — | $101,000 |
| All US (middle half) | $75,500 | $90,000 | $95,250 |
This role: Medline's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs 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 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA9
- Regulatory submissions5
- GMP and compliance3
- Documentation and SOPs3
- Collaboration and leadership3
- Data and digital systems2
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Medline on Regulatory Jobs
- 49
- Open roles
- 37
- Distinct roles
- 21
- Locations
By discipline
- Quality42 86%
- Regulatory7 14%
By level
- Associate & Specialist31 63%
- Senior & Principal11 22%
- Director3 6%
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Regulatory Reporting Specialist at Medline
Open until filled. $67K–$101K a year, employer provided.