QA/RA Lead

Nervio is a startup developing groundbreaking AI-driven medical solutions in the field of intraoperative neurophysiological monitoring (IONM), assisting the surgical team during complex operations. Our lead product is AI-driven software as a medical device (SaMD) that interprets IONM data in real time during surgery. Our solution integrates machine learning, advanced clinical intelligence, and cloud technologies. Nervio operates in Israel and the United States and works in long-term co-development partnerships with leading medtech companies. Job description: We're looking for a hands-on QA/RA Lead to own quality and regulatory for our SaMD, in-house. You will lead and coordinate our regulatory and quality efforts, including directing external consultants who support QMS build and regulatory strategy, and be the internal owner accountable for the QMS, design controls, and the path to marketing authorization. This role reports to the Program Management Office Director. Responsibilities Own the Quality Management System (ISO 13485 / 21 CFR 820 QMSR) and drive it to maturity and audit-readiness. Lead regulatory strategy and execution for device marketing authorization, with FDA 510(k) clearance as the current focus (intended use, predicate, Pre-Sub, submissions), with additional territories added as the product and portfolio grow. Own design controls and the Design History File (DHF); ensure requirements ↔ design ↔ V&V traceability. Coordinate and direct external subcontractors, integrating their work into a single, controlled QMS and DHF. Lead risk management (ISO 14971) governance and cybersecurity/documentation compliance (FD&C §524B, IEC 62304, IEC 62366-1). Manage design reviews, management reviews, change control, CAPA, document/records control, regulatory documentation, and audit readiness (internal/external, FDA and Notified Body). Partner with Product, Project, Engineering, and Data Science to embed quality and regulatory into the Agile/Scrum workflow. Lead post-market surveillance, complaint handling, and vigilance/MDR reporting when on market; review labeling and promotional material for regulatory compliance. Own standards gap analysis and maintain the list of applicable standards; prepare and maintain Technical Documentation and lifecycle regulatory filings (pre- and post-market). Build the RA/QA training plan and execute it- SOPs, processes, and regulatory requirements. Requirements 5+ years in QA and RA for medical devices, with hands-on experience in both regulatory (FDA submissions / 510(k)) and quality (ISO 13485 / QMSR). Working knowledge of the SaMD regulatory framework: IEC 62304, ISO 14971, IEC 62366-1, and applicable FDA guidance. Experience building or maturing a QMS and a design-control system. Ability to lead and coordinate external consultants and cross-functional teams. Ownership mindset- you've shaped QA/RA processes, not only followed them. Strong written and verbal communication skills (Hebrew and English). English fluency must be suitable for U.S. clinical and partner audiences. Bachelor’s in engineering, life sciences, or related; advanced degree an advantage. Strong advantages SaMD / software-device and cybersecurity (IEC 81001-5-1, FD&C §524B) experience. Regulatory experience with AI/ML-enabled SaMD, such as algorithm performance validation and Predetermined Change Control Plans (PCCP). Experience taking a device through FDA clearance or marketing authorization. Hands-on with Azure DevOps for requirements / traceability. Domain exposure to neuromonitoring / neurophysiology or surgical products- a plus. Regulatory experience in additional markets (EU MDR, Australia TGA, or others)- a plus. Experience supporting clinical trials / investigations (e.g., ISO 14155, GCP, IDE)- a plus. Show more Show less