Clinical Subject Matter Expert

Job Description

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

Qualifications

Additional Information

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