MDR Regulatory Reporting Specialist

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Regulatory Reporting Specialist to manage product complaints and MDR reporting under 21 CFR 803. You will review historical and new complaints to determine reportability and ensure compliance with FDA requirements.

The role collaborates cross-functionally with Quality, Regulatory Affairs, R&D, and Operations, prepares MDR submissions via eMDR, and supports global reporting obligations.

Qualifications

• 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).

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.

Skills

FDA MDR knowledge

Regulatory interpretation

Analytical thinking

Cross-functional collaboration

Prioritization

MS Office

Education

Bachelor’s degree in a relevant field

Tools

SAP

TrackWise

Job description

Medline Industries, LP seeks a Regulatory Reporting Specialist to manage product complaints and MDR reporting under 21 CFR 803. You will review historical and new complaints to determine reportability and ensure compliance with FDA requirements.

The role collaborates cross-functionally with Quality, Regulatory Affairs, R&D, and Operations, prepares MDR submissions via eMDR, and supports global reporting obligations.