Quality Compliance Specialist

Job Summary

Working remotely, the full-time Quality Compliance Specialist will evaluate global complaint information, conduct investigations, prepare and submit Medical Device Reporting (MDR) reports to the FDA, and ensure compliance with relevant regulatory requirements.

Key responsibilities

• Assess and investigate complaint information, escalating as necessary
• Prepare and submit MDR reports to the FDA while managing customer relationships during the complaint resolution process
• Lead cross-functional meetings to discuss complaint issues and identify root causes

Required qualifications

• Bachelor's degree with three years of experience in complaint handling and MDR evaluation, or equivalent work experience
• Experience in the medical device, healthcare, or related industry
• Proficient knowledge of medical terms and human anatomy
• Strong familiarity with 21 CFR 820 & 803 regulations
• Proven expertise in MS Office Suite