MDR & Regulatory Reporting Specialist

Medline Industries, Inc. in; 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 an Adverse Event Specialist (Healthcare) to manage product complaints and MDR reporting. The role ensures FDA 21 CFR 803 compliance and leverages decision logic to determine reportability, coordinating with Quality, Regulatory Affairs, and R&D.

The position requires a bachelor's degree and 1+ year of relevant experience in regulated environments. The company offers a comprehensive benefits package and opportunities for growth within a large, global organization.

Qualifications

• Familiarity with FDA Medical Device Reporting (21 CFR 803).
• Experience interpreting complaint narratives and determining event severity.
• Ability to apply decision logic for MDR reporting.
• Comfort working cross‑functionally with Quality, Regulatory Affairs, R&D and Operations.

Responsibilities

• Review new and historical product complaints for data completeness and reportability.
• Evaluate MDR reportability under 21 CFR 803 using current criteria and decision logic.
• Collaborate with internal teams to gather missing information for accurate reporting.
• Prepare and submit MDRs through the FDA eMDR portal for reportable events.
• Coordinate with international regulatory contacts to support global reporting obligations.

Skills

FDA MDR knowledge

Data interpretation

Cross‑functional collaboration

Regulatory compliance

Analytical thinking

Attention to detail

Education

Bachelor's degree in a relevant field

Tools

SAP

TrackWise

Microsoft Office

Job description

Medline Industries, LP is seeking an Adverse Event Specialist (Healthcare) to manage product complaints and MDR reporting. The role ensures FDA 21 CFR 803 compliance and leverages decision logic to determine reportability, coordinating with Quality, Regulatory Affairs, and R&D.

The position requires a bachelor's degree and 1+ year of relevant experience in regulated environments. The company offers a comprehensive benefits package and opportunities for growth within a large, global organization.