Hybrid Regulatory Affairs, Quality Assurance

at ABCDx SA

• Job title: Regulatory Affairs, Quality Assurance
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, Barcelona, Spain

About the role

• Hands-on RA/QA leader at ABCDx developing innovative brain injury diagnostics. Leading EU IVDR and FDA compliance while leveraging AI for quality assurance.

Responsibilities

• Own and continuously improve our **ISO 13485 QMS** (document control, CAPA, audits, supplier quality, training).
• Keep us **audit-ready**—leading Notified Body, supplier, and FDA inspections with confidence.
• Drive **IVDR (Annex II/III)** and **FDA 510(k)** submissions and act as the main liaison with regulatory authorities and consultants.
• Develop forward-looking regulatory strategies aligned with our innovation roadmap.
• Ensure **end-to-end DHF/DMR traceability** and maintain **ISO 14971 risk management files**.
• Coordinate analytical and clinical performance studies, technical documentation, and labeling.
• Oversee compliance with **IEC 62304, IEC 82304-1, IEC 62366-1**, and applicable SaMD/AI guidance.
• Maintain robust cybersecurity and data integrity procedures.
• Deploy **AI and eQMS workflows** for documentation, audit prep, PMS summaries, and DHF/DMR updates.
• Define **SOPs for AI use**, ensuring validation, data governance, and compliance.
• Run **PMS/PMPF plans**, handle vigilance activities, and ensure proactive CAPA and trend analysis.

Requirements

• **Education** – Degree in Life Sciences, Biomedical Engineering, or related field (MSc preferred).
• **Experience** – 3-5 years in RA/QA for IVDs or medical devices, ideally in a start-up or scale-up.
• **Proven Expertise** – ISO 13485 QMS operation, Notified Body audits, and FDA interactions.
• **Track Record** – Contribution to IVDR CE-marking and FDA 510(k) submissions.
• **Technical Mastery** – Deep knowledge of ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1.
• **AI Fluency** – Experience using AI tools in regulated environments (documentation, audits, PMS) with validation and governance controls.
• **Collaboration & Communication** – Clear communicator, proactive partner, fluent in English.

Benefits

• Be part of a mission-driven company with a direct impact on **saving lives**.
• Work in a **purpose-driven, self-managed startup** with real autonomy.
• Join a team that values **honesty, curiosity, and collaboration **over hierarchy.
• Have the freedom to experiment, learn, and innovate without fear of failure.
• The opportunity to shape and execute a modern, **AI-enabled RA/QA framework** for breakthrough diagnostics.
• Work in a beautiful office in an UNESCO world heritage site in Barcelona with one of the **best rooftop views** in the city, but also freedom for **remote working and flexible **work schedule