Medical Device Reporting Analyst

Job Summary

A company is looking for a Global MDR Submissions Analyst III.

Key Responsibilities

• Review and resolve complex medical device complaints, ensuring appropriate documentation and compliance with regulatory requirements
• Coordinate complaint-related tasks with cross-functional teams and prepare submissions for regulatory bodies
• Mentor junior staff and provide training on complaint processing and regulatory compliance

Required Qualifications

• Bachelor of Science degree or Associate of Science with Licensure in Nursing from an accredited institution
• Minimum of 3 years of experience in the medical device industry or healthcare/clinical setting
• Knowledge of Medical Device Quality Systems regulations, including ISO 13485 and 21 CFR standards
• Basic understanding of medical terminology and human anatomy
• Proficiency in Microsoft Excel and Word applications