Clinical MDR Specialist

Job Summary

A company is looking for a Product Surveillance Clinical MDR Specialist I (Remote).

Key Responsibilities

• Evaluate and investigate complaints related to adverse events for regulatory reporting
• Submit adverse event reports to regulatory agencies in compliance with regulations
• Maintain documentation and correspond with stakeholders regarding complaints and adverse events

Required Qualifications

• Bachelor's degree in Health Sciences, Biomedical Engineering, Nursing, Risk Management, or a related field
• Preferred experience in the medical device or drug/pharma industry with adverse event reporting
• Knowledge of FDA 21 CFR 820, cGMP, ISO13485:2016, and international regulations
• Proficiency in PC programs, particularly Excel and Word
• Ability to interpret technical instructions and apply mathematical principles as needed