QARA

Deegit Inc. Job Description: - The Clinical Subject Matter Expert (SME) will be responsible for the clinical support of device risk management activities. - SME will have the following responsibilities: - 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 deviceKey skills and experience: - A degree in a clinical related field (RN, MD) - 10 years of clinical experienceAdditional skills (Desirable) - 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)Skill and Experience Details: Minimum Experience Required: Mandatory Skills: Medical Data Acquisition and Storage Consulting Desirable Skills: Clinical Systems, Medical Devices - QARA Language Skills: English Language All your information will be kept confidential according to EEO guidelines.