QARA Consultant at Deegit Inc

QARA Consultant ### Job Description - 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) ###…