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." Apply tot his job