Regulatory Reporting Specialist

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

Benefits offered by this job

Health insurance

Life and disability coverage

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Regulatory Reporting Specialist to manage product complaint remediation and MDR reporting. The role reviews historical and new complaints to determine MDR reportability in alignment with FDA requirements and 21 CFR 803, ensuring submissions are complete and compliant.

The ideal candidate will work cross-functionally with Quality, Regulatory Affairs, R&D, and Operations to gather missing information, prepare MDRs in the FDA eMDR portal, and support global

Qualifications

• 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.

Responsibilities

• Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards.
• Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria and decision logic.
• Work cross-functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing information for accurate reportability assessments.
• Prepare and submit MDRs through the FDA’s eMDR portal for newly identified reportable events.
• Collaborate with international regulatory contacts to determine and support global reporting obligations.

Skills

FDA MDR knowledge

Regulatory affairs

Analytical thinking

Cross-functional collaboration

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.

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.

Minimum Job Requirements

• 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-functionally 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.

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.
• Medline will not pay less than the applicable minimum wage or salary threshold.

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.

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.

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.

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.

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.