MDR Regulatory Reporting Specialist

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

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