MDR Regulatory Reporting Specialist

Medline Industries, Inc. in; Mundelein (IL); Sur place; USD 67 000 - 101 000; Plein temps

Résumé du poste

Medline Industries, LP is seeking a Regulatory Reporting Specialist to manage MDR determination and complaint remediation. You will review historical and new complaints for reportability under FDA rules, ensuring 21 CFR 803 compliance and proper data capture.

You will work with Quality, Regulatory Affairs, R&D, and Operations to gather required information and submit MDRs electronically. Prior MDR/regulated industry experience is preferred.

Qualifications

• Bachelor’s degree in a relevant field.
• 1+ year of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or related regulated industry experience.

Responsabilités

• Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards and internal procedures.
• 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 and other internal partners to gather missing information for accurate assessments.
• Prepare and submit MDRs through FDA eMDR portal for newly identified reportable events.
• Coordinate with international regulatory contacts to support global reporting obligations.

Formation

Bachelor’s degree in a relevant field

1+ year of experience in complaint handling/MDR evaluation/regulatory affairs

Outils

SAP

TrackWise

Description du poste

Medline Industries, LP is seeking a Regulatory Reporting Specialist to manage MDR determination and complaint remediation. You will review historical and new complaints for reportability under FDA rules, ensuring 21 CFR 803 compliance and proper data capture.

You will work with Quality, Regulatory Affairs, R&D, and Operations to gather required information and submit MDRs electronically. Prior MDR/regulated industry experience is preferred.