Spec Regulatory Reporting

Medline; Mundelein (IL); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP, is seeking a Regulatory Reporting Specialist to manage product complaint remediation and determine MDR reportability in line with FDA requirements. You will review historical and new complaints to ensure data completeness and accurate reporting under 21 CFR 803 and 820.198, coordinating with Quality, Regulatory Affairs, R&D, and Operations to gather missing information.

The role includes preparing and submitting MDRs via the FDA eMDR portal and supporting global reporting

Qualifications

• Bachelor's degree in a relevant field and 1+ year of complaint handling or MDR evaluation experience.
• Understanding of FDA MDR (21 CFR 803) and complaint handling requirements (21 CFR 820.198).
• Ability to interpret medical descriptions and narratives to determine event severity and regulatory obligations.
• Strong analytical and cross-functional communication skills.
• Proficient in Microsoft Word, Excel, PowerPoint.

Responsibilities

• Review new and historical product complaints for data completeness and reportability decisions.
• Evaluate MDR reportability under 21 CFR 803 using current criteria and decision logic.
• Collaborate with Quality, Regulatory Affairs, R&D, Operations to gather missing information.
• Prepare and submit MDRs through FDA eMDR portal for newly identified reportable events.
• Collaborate with international regulatory contacts to support global reporting obligations.

Skills

Analytical thinking

Cross-functional collaboration

Prioritization

Microsoft Office

Education

Bachelor's degree in a relevant field

Tools

SAP

TrackWise

Job description

Job Summary

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.

Job Description

Responsibilities

• 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.

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 / Skill / 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 requirements

• 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.

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.