MDR Regulatory Reporting Specialist

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

Benefits offered by this job

Competitive total rewards package

Job summary

Medline Industries, LP is seeking a Regulatory Reporting Specialist to review and correlate product complaints for MDR reportability under FDA regulations and 21 CFR 803. This role ensures complete data collection and accurate regulatory decisions across Quality, Regulatory Affairs, and R&D teams.

The candidate will prepare MDR submissions via the FDA eMDR portal and coordinate with international regulatory partners to meet global reporting obligations.

Qualifications

• Bachelor's degree in a relevant field and 1+ year of experience in complaint handling or regulatory affairs.
• Experience with FDA reporting requirements (21 CFR 803) and post-market surveillance.
• Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.

Responsibilities

• Review new and historical product complaints to verify data completeness and ensure MDR reporting decisions align with regulatory standards.
• Evaluate complaint files to determine MDR reportability under 21 CFR 803, applying current criteria and decision logic.
• Collaborate with Quality, Regulatory Affairs, R&D, Operations to gather missing information for reportability assessments.
• Prepare and submit MDRs through FDA eMDR portal for newly identified reportable events.
• Support global reporting obligations by coordinating with international regulatory contacts when needed.

Skills

Analytical thinking

Cross-functional collaboration

Attention to detail

Time management

Education

Bachelor's degree in a relevant field

Tools

SAP

TrackWise

Job description

Medline Industries, LP is seeking a Regulatory Reporting Specialist to review and correlate product complaints for MDR reportability under FDA regulations and 21 CFR 803. This role ensures complete data collection and accurate regulatory decisions across Quality, Regulatory Affairs, and R&D teams.

The candidate will prepare MDR submissions via the FDA eMDR portal and coordinate with international regulatory partners to meet global reporting obligations.