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 device
Key skills and experience:
- A degree in a clinical related field (RN, MD)
- 10 years of clinical experience
Additional 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.
