Medical Device Regulatory Expert: OneDrive DHF Audit
2 weeks ago
Job summary
We are developing a sophisticated medical device that integrates Mechanical Design, Electrical Hardware, Firmware and AI Models. We are looking for a Quality/Regulatory specialist to audit our current project structure on OneDrive and reorganize it into a compliant Design History File (DHF) and Device Master Record (DMR).Responsibilities
- Review our current folders- (Versions,Electrical,Mechanical,Ai,Firmware)
- Identify missing regulatory documents required for FDA Class II/III submission
- Ensure all design inputs outputs and verification/validation reports linked traceable.
Job description
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