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 MDR submissions for regulatory bodies
• Mentor lower-level staff and support training initiatives related to complaint processing and regulatory compliance

Required Qualifications

• Bachelor of Science degree or Associate of Science and Licensure in Nursing from an accredited institution
• Minimum of 3 years of experience in a healthcare or clinical setting, or equivalent combination of medical device and clinical experience
• Demonstrated knowledge of medical device quality systems regulations including ISO 13485 and 21CFR803
• Experience with complaint handling and adverse event reporting in the medical device industry preferred
• Ability to work under pressure and meet deadlines in a regulated environment