13 publicaciones de empleo destacadas de laboratory manager en madrid madrid provincia (¡Están contratando!)

Regulatory & Quality Lead – AI IVD Diagnostics
SpotLab —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Español
- Inglés
- Bachillerato
Solicitud rápida
Virtual/ Inside Sales Account Manager (m/f/d) – Microbiology Division
Thermo Fisher Scientific —Alcobendas, Madrid provincia
- Jornada completa
- CRM software
- Ventas
- Salesforce
Global Governance & Regulation Lead - Travel & Expense Management (f/m/d)
Siemens Healthineers —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Grado
- Administración y dirección de empresas
11d
Diagnostic Liason - Galicia y Castilla y León
AstraZeneca —Madrid, Madrid provincia
- Jornada completa
- Microsoft Excel
- Doctorado
- Ventas
8d
Field Applications Specialist (f/m/d)
Beckman Coulter Diagnostics —La Moraleja, Madrid provincia
- Jornada completa
- Inglés
- Oficina
- Grado
- Seguro dental
- Vacaciones pagadas
12d
Senior Feasibility Associate / Feasibility Manager
Precision for Medicine —Madrid, Madrid provincia
- Teletrabajo
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Solicitud rápida
Senior Feasibility Associate / Feasibility Manager
Precision Medicine Group —Madrid, Madrid provincia
- Teletrabajo
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Customer Service Coordinator, WITS
Beckman Coulter Diagnostics —La Moraleja, Madrid provincia
- Jornada completa
- Español
- Oracle
- Servicio al cliente
LIS Manager
CBRE —Tres Cantos, Madrid provincia
- Jornada completa
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
LIMS Project Lead
Accenture —Madrid, Madrid provincia
- Jornada completa
- Inglés
Pavement Engineer
AECOM —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- AutoCAD
- Microsoft Excel
- Microsoft Office
- Seguro dental
- Vacaciones pagadas
Geotechnical Engineer F/M - Ingénieur Géotechnique F/H - Éolien/Wind Offshore
Q ENERGY —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Inglés
- Máster
- Project management
Solicitud rápida
Brake System Engineer - Alstom Ametsis
ALSTOM —Madrid, Madrid provincia
- Jornada completa
- Inglés

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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

Refina tu búsqueda

laboratory manager empleos en madrid madrid provincia

Regulatory & Quality Lead – AI IVD Diagnostics

Virtual/ Inside Sales Account Manager (m/f/d) – Microbiology Division

Global Governance & Regulation Lead - Travel & Expense Management (f/m/d)

Diagnostic Liason - Galicia y Castilla y León

Field Applications Specialist (f/m/d)

Senior Feasibility Associate / Feasibility Manager

Senior Feasibility Associate / Feasibility Manager

Customer Service Coordinator, WITS

LIS Manager

LIMS Project Lead

Pavement Engineer

Geotechnical Engineer F/M - Ingénieur Géotechnique F/H - Éolien/Wind Offshore

Brake System Engineer - Alstom Ametsis

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