Complaint Specialist - MDR Remediation

Responsibilities

(Complaint Specialist) - MDR Remediation

Seeking contingent workers to supportMedical Device Reporting (MDR) remediation activities , with a focus onretrospective complaint review reportability assessmentsunder FDA requirements.

Core Experience We Are Looking For

Candidates should have hands-on experience reviewing both historical and newly received product complaints to determine MDR reportability in compliance with FDA regulations (21 CFR Part 803) . This role is remediation?driven and requires individuals who can apply current regulatory criteria and decision logic consistently across large complaint populations.

Key Responsibilities:

• Review historical complaint files as part of a remediation or retrospective review effort to verify completeness and reassess MDR reportability decisions.
• Apply current FDA MDR definitions, criteria, and decision trees to legacy complaints to determine whether an MDR should have been filed.
• Identify missing or incomplete data within complaint records and work cross?functionally (Quality, Regulatory, Operations, etc.) to obtain necessary information for a defensible decision.
• Prepare and submit MDRs through the FDAs electronic MDR (eMDR) system when remediation identifies reportable events.
• Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines.

Required Background & Skill Set

• ABachelors degreein a relevant fieldand at least 1+ year of experience in complaint handling, MDR evaluation, post?market surveillance, or similar regulated industry experience.
• Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.
• Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
• Experience managing high?volume documentation reviews or participating in large?scale remediation or retrospective review projects.
• Strong analytical skills, attention to detail, and the ability to apply updated regulatory logic consistently across many records.

Preferred Experience

• 2+ years of MDR reporting or complaint remediation experience in a medical device, pharmaceutical, or healthcare environment.
• Experience working in remediation environments with aggressive deadlines and throughput expectations .
• Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms .

Key Traits & Behavioral Attributes for Success:

• Strong attention to detail Able to carefully review complaint records, medical narratives, and regulatory fields to ensure accuracy and audit?defensible MDR decisions
• Clear and professional communication skills Comfortable documenting rationale, escalating questions, and collaborating cross?functionally to resolve missing or unclear data
• Quick learner Able to rapidly understand internal procedures, MDR decision logic, and remediation workflows in a fast?paced environment
• Analytical and critical thinking skills Capable of applying current MDR definitions and regulatory criteria consistently across large volumes of legacy complaints
• Time management and prioritization skills Able to manage high?volume remediation work while meeting strict regulatory and remediation timelines
• Comfort working in structured, compliance?driven environments Understands the importance of following procedures and producing consistent, traceable decisions