Regulatory Affairs

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.

**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