Senior Quality Compliance Specialist

Job Summary

Senior Quality Compliance Specialist, responsible for complaint handling and Medical Device Reporting (MDR) in a full-time remote position, evaluates global complaint information, prepares and submits MDR reports, and ensures compliance with FDA and ISO requirements.

Key Responsibilities

• Assess and investigate complaint information, escalating as needed
• Prepare and submit MDR reports to the FDA and manage customer relationships during investigations
• Lead meetings to discuss complaint issues and analyze complaint data to identify root causes

Required Qualifications

• Bachelor's degree and five years of experience in complaint handling and MDR evaluation
• Experience in the medical device or healthcare industry
• Proficient knowledge of medical terms and human anatomy
• Strong familiarity with 21 CFR 820 & 803 regulations
• Experience with Good Documentation Practices (GDP) related to complaint filing