Regulatory Affairs & Quality Assurance

Overview

Join a mission-driven team focused on changing the future of brain injury diagnostics. ABCDx is building AI-powered, life-saving diagnostic technologies such as ThromboCheck (FDA-bound point-of-care D-dimer) and LVOCheck (prehospital diagnostic support for LVO stroke). We’re seeking a hands-on RA/QA leader to drive regulation, innovation, and AI-enabled quality across EU and US regulatory landscapes.

Responsibilities

• Quality & Compliance: Own and continuously improve the ISO 13485 QMS (document control, CAPA, internal audits, supplier quality, training); maintain audit readiness and lead Notified Body, supplier, and FDA inspections with confidence.
• Regulatory Affairs: Drive IVDR (Annex II/III) and FDA 510(k) submissions; act as the primary liaison with regulatory authorities and consultants; develop forward-looking regulatory strategies aligned with the innovation roadmap.
• Design, Risk & Clinical: En...