Quality Compliance Specialist, Complaint Handling – MDR Reporting

Role Overview

• Evaluate global complaint information provided and conduct additional investigation as needed and escalate as appropriate
• Prepare and submit MDR reports to FDA
• Process complaint files from initiation to closure
• Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit
• Manage customer relationship and expectations during course of complaint investigation and resolution process
• Lead and plan agenda for and run weekly meetings to discuss complaint issues with affected functions

Requirements

• Bachelor's degree plus three (3) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting)
• Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience.
• Experience submitting Medical Device Reports
• Proficient knowledge of medical terms and human anatomy
• Good knowledge of Good Documentation Practices (GDP)
• Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
• Proven expertise in MS Office Suite and ability to operate general office machinery
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Demonstrated problem-solving, critical thinking, and investigative skills

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs