MDR Regulatory Reporting Specialist

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

Job summary

Medline Industries, LP is seeking a Regulatory Reporting Specialist to review product complaints for MDR reportability and ensure FDA 21 CFR 803 compliance. The role collaborates with Quality, Regulatory Affairs, R&D, and Operations to gather necessary information and submits MDRs via the FDA eMDR portal.

The candidate will interpret medical narratives, apply decision logic, and maintain timelines for remediation and reporting. Experience with SAP/TrackWise is preferred.

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, internal procedures, and decision trees.

Skills

Complaint handling

MDR evaluation

Regulatory affairs

Data interpretation

Cross-functional collab

Multitasking

MS Office

FDA regulations

Education

Bachelor’s degree

Tools

SAP

TrackWise

Job description

Medline Industries, LP is seeking a Regulatory Reporting Specialist to review product complaints for MDR reportability and ensure FDA 21 CFR 803 compliance. The role collaborates with Quality, Regulatory Affairs, R&D, and Operations to gather necessary information and submits MDRs via the FDA eMDR portal.

The candidate will interpret medical narratives, apply decision logic, and maintain timelines for remediation and reporting. Experience with SAP/TrackWise is preferred.