Senior Quality Compliance Specialist

A company is looking for a Senior Quality Compliance Specialist - MDR Reporting.

Key Responsibilities

Evaluate global complaint information and conduct investigations as needed

Prepare and submit Medical Device Reporting (MDR) reports to the FDA

Lead investigations of complaints and manage customer relationships throughout the resolution process

Required Qualifications

Bachelor's Degree

Five (5) years of experience in complaint handling and evaluating complaints for MDR

Experience in the medical device, healthcare, or related industry

Knowledge of 21 CFR 820 & 803 regulations

Proficiency in MS Office Suite