QARA Consultant

· Review and approval of the clinical workflow definitions for the subject devices

· Identification of the clinical hazards and associated harms for the subject devices

· Estimation of the severity and probability of occurrence for the clinically related hazardous situation

· Development of the clinical benefit statements for the subject device

· Understanding of device development in an FDA regulated environment

· Experience with ISO 14971 risk management activities

· Experience with the post market medical device support (complaint or risk analysis)

All your information will be kept confidential according to EEO guidelines.