Strategic MDR Regulatory Reporting Specialist

Medline; Chicago (IL); Sur place; USD 67 000 - 101 000; Plein temps

Résumé du poste

Medline is seeking a Regulatory Reporting Specialist to manage product complaint remediation and assess MDR reportability in alignment with FDA requirements. You will review historical and new complaints, determine reportability, and ensure submissions via eMDR are accurate and timely.

The role involves cross-functional collaboration with Quality, Regulatory Affairs, R&D, and Operations, plus interaction with international regulators to support global reporting obligations.

Qualifications

• 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.
• Knowledge 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.

Responsabilités

• 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.

Connaissances

FDA MDR knowledge

Complaint handling

Analytical skills

Cross-functional collaboration

Microsoft Office

Formation

Bachelor’s degree in a relevant field

Outils

SAP

TrackWise

Description du poste

Medline is seeking a Regulatory Reporting Specialist to manage product complaint remediation and assess MDR reportability in alignment with FDA requirements. You will review historical and new complaints, determine reportability, and ensure submissions via eMDR are accurate and timely.

The role involves cross-functional collaboration with Quality, Regulatory Affairs, R&D, and Operations, plus interaction with international regulators to support global reporting obligations.