Join a Mission-Driven Team, Where Impact Comes First
At ABCDx, we’re not just building a business—we’re changing the future of brain injury diagnostics. Our technology has the potential to save lives, and we need the right people to help bring it to the world.
Our pipeline includes ThromboCheck (FDA-bound point-of-care D-dimer) and LVOCheck (prehospital diagnostic support for LVO stroke). Both are designed to make a real-world difference—and we need people who want to do the same.
How You’ll Make a Difference
We’re looking for a hands-on RA/QA leader who thrives at the intersection of regulation, innovation, and AI-driven quality. You’ll lead our EU IVDR and FDA compliance, operate our ISO 13485 QMS across Spain and Switzerland, and pioneer how AI can safely and intelligently support regulatory and quality activities.
Here’s what impact looks like in this role:
Quality & Compliance
- 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.
Regulatory Affairs
- 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.
Design, Risk & Clinical
- Ensure end-to-end DHF/DMR traceability and maintain ISO 14971 risk management files.
- Coordinate analytical and clinical performance studies, technical documentation, and labeling.
Software & Cybersecurity
- Oversee compliance with IEC 62304, IEC 82304-1, IEC 62366-1, and applicable SaMD/AI guidance.
- Maintain robust cybersecurity and data integrity procedures.
AI-Enabled RA/QA Operations
- 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.
- Use AI responsibly to monitor regulatory changes, assess gaps, and identify continuous improvement opportunities.
Post-Market & Continuous Improvement
- Run PMS/PMPF plans, handle vigilance activities, and ensure proactive CAPA and trend analysis.
What It’s Like to Work at ABCDx
Impact Beyond Compliance
This isn’t about checking boxes—it’s about building trust in life-saving technology. Your work ensures our innovations reach patients safely and faster.
Ownership Without Hierarchy
We operate in a self-management structure—no titles, no micromanagement, just accountability and collaboration. Everyone has a voice.
Innovation With Integrity
We believe AI belongs in medtech regulation, but only when paired with human judgment, validation, and ethics. You’ll help define what that looks like.
Freedom & Responsibility
Flexible hybrid work from Barcelona, impact over hours, and the freedom to lead your work your way.
- 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.
- 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
