We have received more than 10 international awards, including the Seal of Excellence of the European Union. We are a multidisciplinary team with gender parity where engineers, doctors, clinical researchers, business managers, and others with diverse professional backgrounds complement each other.

Key Responsabilities

• Lead the CE marking plan and execution to certify AI-based IVD diagnostic products.
• Own IVDR regulatory strategy and align product roadmap, evidence, and documentation to regulatory timelines.
• Evolve and maintain a scalable QMS (ISO 13485-aligned).
• Drive technical documentation and conformity assessment readiness.
• Implement risk management and PMS/vigilance processes.
• Coordinate with notified bodies and authorities.
• Work with AI/engineering to ensure compliance with EU AI Act obligations.
• Support regulatory audits, internal audits, and supplier evaluation meetings

Job requirements

• Experience in SaMD (Software as a Medical Device) regulatory frameworks and compliance activities.
• Experience with EU medical device regulations, including IVDR (EU) 2017/746 and/or MDR (EU) 2017/745.
• Understanding of emerging AI regulations in healthcare, including the EU AI Act, and the ability to translate them into practical compliance actions.
• Proven ability to interpret and apply regulatory requirements specifically for AI-based systems in the medical sector.
• Excellent analytical skills, with strong attention to detail and clear, structured communication (written and verbal).
• Advanced English and Spanish proficiency (verbal and written).
• Ability to thrive in a fast-changing environment and collaborate effectively with multidisciplinary teams.
• University degree in Engineering, Medicine, Pharmacy, Law, or another relevant scientific discipline.