Medical Device Regulatory Expert: OneDrive DHF Audit & Restructuring (FDA, FCC, MET)
Job Overview: 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).
Our goal is to ensure that our documentation is "audit-ready" for FDA 21 CFR 820, FCC Part 15/18, and MET (IEC 60601-1) certifications.
Key Responsibilities:
Audit & Restructure: Review our current folders (Versions, Electrical, Mechanical, AI, Firmware) and map them to a formal DHF structure.
Gap Analysis: Identify missing regulatory documents required for FDA Class II/III submission and safety certifications.
Traceability Matrix: Ensure all design inputs, outputs, and verification/validation (V&V) reports are linked and traceable.
Compliance Mapping: Verify that the Firmware folder structure aligns with IEC 62304 and the Electrical folder supports MET/UL safety evidence requirements.
Required Qualifications:
MedTech Expertise: Proven experience in Medical Device Regulatory Affairs (RA) or Quality Systems (QA).
Standards Knowledge: Deep familiarity with ISO 13485, FDA 21 CFR Part 820, IEC 60601-1 (Safety), and IEC 62304 (Software Lifecycle).
Technical Literacy: Ability to understand technical documentation for PCB designs, CAD files, and AI algorithm validation.
Cloud Organization: Experience managing structured documentation specifically within OneDrive/SharePoint.
Preferred Experience:
Experience with AI/Machine Learning documentation for medical software (SaMD).
Experience assisting startups in moving from "Development" to "Regulatory Submission."
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