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Deegit Inc logo

Posted 3 months ago

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QARA Consultant

MinneapolisOn-site

AI Summary

Reviews and approves clinical workflow definitions for medical devices, identifies clinical hazards and harms, estimates severity and probability, and develops clinical benefit statements within an FDA-regulated environment.

About this role

QARA Consultant

Deegit Inc.

·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)

Additional Information

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

Skills

Clinical Risk ManagementClinical Workflow DefinitionsComplaint HandlingFDA RegulationsHazard AnalysisISO 14971Post-market Medical Device SupportRisk Analysis

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