MDR Regulatory Reporting Specialist - FDA eMDR Expert

Medline; Chicago (IL); Presencial; USD 67.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Life and disability coverage

401(k) contributions

Paid time off

Descripción de la vacante

Medline Industries, LP is seeking a Regulatory Reporting Specialist to manage product complaint remediation and MDR reporting. The role reviews historical and new complaints to determine MDR reportability in alignment with FDA requirements and 21 CFR 803, ensuring submissions are complete and compliant.

The ideal candidate will work cross-functionally with Quality, Regulatory Affairs, R&D, and Operations to gather missing information, prepare MDRs in the FDA eMDR portal, and support global

Formación

• 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.

Responsabilidades

• Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards.
• Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria and decision logic.
• Work cross-functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing information for accurate reportability assessments.
• Prepare and submit MDRs through the FDA’s eMDR portal for newly identified reportable events.
• Collaborate with international regulatory contacts to determine and support global reporting obligations.

Conocimientos

FDA MDR knowledge

Regulatory affairs

Analytical thinking

Cross-functional collaboration

Microsoft Office

Educación

Bachelor's degree in a relevant field

Herramientas

SAP

TrackWise

Descripción del empleo

Medline Industries, LP is seeking a Regulatory Reporting Specialist to manage product complaint remediation and MDR reporting. The role reviews historical and new complaints to determine MDR reportability in alignment with FDA requirements and 21 CFR 803, ensuring submissions are complete and compliant.

The ideal candidate will work cross-functionally with Quality, Regulatory Affairs, R&D, and Operations to gather missing information, prepare MDRs in the FDA eMDR portal, and support global