20 publicaciones de empleo destacadas en image drive (¡Están contratando!)

Regulatory & Quality Lead – AI IVD Diagnostics
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- Jornada completa
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- Español
- Inglés
- Bachillerato
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eDreams ODIGEO —Barcelona, Barcelona provincia
- Google Suite
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Beazley Management Limited —Barcelona, Barcelona provincia
- Teletrabajo
- Español
- Inglés
- Microsoft Office
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Marc Jacobs —Madrid, Madrid provincia
- Media jornada
- Ventas
- Inglés
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Michael Kors —Madrid, Madrid provincia
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- CRM software
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Tether Operations Limited —Barcelona, Barcelona provincia
- Jornada completa
- Teletrabajo
- Doctorado
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Swiss Re —Madrid, Madrid provincia
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TELUS Digital —Barcelona, Barcelona provincia
- Informática
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- Java
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Glovo —Barcelona, Barcelona provincia
- Horas extra
- Salesforce
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Miin Cosmetics —Madrid, Madrid provincia
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Worley —Madrid, Madrid provincia
- AutoCAD
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Miiro Borneta Hotel —Barcelona, Barcelona provincia
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- Español
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AI Research Engineer (Model Compression & Quantization)
Tether Operations Limited —Barcelona, Barcelona provincia
- Jornada completa
- Teletrabajo
- Doctorado
- Informática
- Inglés
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Miiro Borneta Hotel —Barcelona, Barcelona provincia
- Jornada completa
- Español
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Wingtra AG —Barcelona, Barcelona provincia
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Opella Healthcare Group —Barcelona, Barcelona provincia
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QMenta —Barcelona, Barcelona provincia
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- Trabajo híbrido
- Español
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BNP Paribas —Madrid, Madrid provincia
- Jornada completa
- Microsoft Excel
- Inglés
- Máster
Senior Manager Data Science
Solera —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Machine learning
- Python
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Bain & Co. —Madrid, Madrid provincia
- Jornada completa
- Azure
- Doctorado
- Informática
- Seguro dental
- Vacaciones pagadas
Solicitud rápida

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Regulatory & Quality Lead – AI IVD Diagnostics

SpotLab -
Madrid, Madrid provincia

Solicitud rápida

Detalles del empleo

Jornada completa

Cualificaciones

ESO
Español
Inglés
Bachillerato
Grado
Farmacia
Inteligencia artificial

Descripción completa del empleo

We are facing a real challenge and looking for the right person to join our adventure.

SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting-edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help us streamline processes and navigate regulatory changes to ensure compliance.

SpotLab has built a solid foundation in quality and regulatory affairs, including: the In Vitro Medical Device Manufacturer License granted by the Spanish Medicines Agency, a Quality Management System following ISO 13485 standards, CE Marking for two AI diagnostic products under the IVDD, and ISO 27001 certification. Now, we need to continue evolving our approach for the dynamic regulatory landscape.

This role offers a meaningful mission: you will help certify AI models for microscopy images in hematology and infectious diseases —pioneering a new era with real impact on patients' lives worldwide.

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.
Act as the company’s PRRC (Person Responsible for Regulatory Compliance) for IVD 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

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, Biotechnology, Law, or another relevant scientific discipline.

Solicitud rápida

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