About the company

Biorce is a pioneering Healthtech company dedicated to revolutionizing drug development through the power of AI. We are passionate about accelerating medical advancements and improving patient outcomes.

Our team comprises seasoned clinical research professionals, data scientists, and AI experts, working collaboratively to bridge the gap between cutting-edge technology and real-world clinical needs.

With an unwavering commitment to revolutionize healthcare, we envision a world where all patients benefit from accelerated and cost-effective access to treatments. Biorce is poised to redefine the landscape of healthcare, shaping a future where innovation and accessibility converge for the betterment of humanity.

About the role

Following our successful expansion into the U.S. and continued growth across Europe, we are seeking a Quality and Regulatory Affairs Manager, QARA Responsible, to help drive our Quality and Regulatory Affairs function from our Austin / Barcelona hub.

Reporting directly to our leadership team, this person will play a critical role in defining and owning the regulatory and quality framework that governs the company's AI-powered clinical trial platform, from protocol generation through patient monitoring.

This role will work in close partnership with the Head of Security, who owns security and data governance, to ensure the full product stack meets applicable regulatory requirements across all target markets.

Who We’re Looking For

We are looking for an experienced Quality and Regulatory Affairs Manager with strong hands-on experience in software as a medical device, quality management systems, and regulatory frameworks for AI-powered healthcare products.

Someone who has worked on medical devices based on software and has direct experience building or auditing ISO 13485 QMS in a software or SaMD company. This person should be able to define, implement, and maintain the quality and regulatory framework needed to support a regulated AI-powered clinical trial platform across multiple markets.

Key Responsibilities

• Define and own the regulatory and quality framework that governs the company's AI-powered clinical trial platform.
• Ensure regulatory and quality coverage across the full product stack, from protocol generation through patient monitoring.
• Build, maintain, and continuously improve the company’s QMS in line with ISO 13485 and applicable software/SaMD standards.
• Develop and manage SOPs, quality documentation, and audit readiness processes under IEC 62304 and related regulatory frameworks.
• Support MDR or IVDR conformity assessment activities with Notified Bodies.
• Drive implementation of applicable AI regulatory requirements, including EU AI Act or equivalent high-risk AI regulatory work.
• Ensure GxP/CSV expectations are addressed in the context of SaaS platforms.
• Partner closely with the Head of Data on areas where regulatory, quality, security, and data governance requirements intersect.

✅ Must-haves

• Must have been working on medical devices based on software, with 5+ years in QARA and experience in medical environments.
• Direct hands-on experience building or auditing ISO 13485 QMS in a software/SaMD company.
• Deep working knowledge of IEC 62304, not just awareness, but having written SOPs and managed audits under it.
• Practical experience with EU AI Act implementation or equivalent high-risk AI regulatory work.
• Has navigated at least one MDR or IVDR conformity assessment with a Notified Body.
• Understands GxP/CSV in the context of SaaS platforms, not just on-premise validated systems.
• Familiarity with eCTD / regulatory submission formats is a strong plus given the submissions module.

✨ Nice-to-Haves

• Experience in startups.
• Experience in healthcare.
• Experience working with AI-powered clinical, regulatory, or medical software platforms.
• Experience supporting regulatory submissions or submission-readiness processes.
• Ability to operate in a fast-moving environment while maintaining strong quality and regulatory standards.

Why Join Us?

• A dynamic work environment with an international team, where collaboration and diversity thrive.
• Work alongside top talent, united by a shared purpose and committed to making a real impact.
• Comprehensive private health coverage to ensure your physical and mental well-being.
• Hybrid work model offering flexibility to balance your professional and personal life.
• Company events to celebrate achievements and enjoy time together.
• Get equipped with a MacBook to enhance your productivity and work experience.
• Our office is pet-friendly! You’ll likely be greeted by a few wagging tails upon arrival.

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By submitting this application, I agree that my personal data will be collected, processed, and retained by the company solely for the purposes of managing and assessing my candidacy.