Quality and Regulatory Manager for Health AI Products

hace 2 semanas

MADRID Maryland Spain SpotLab A tiempo completo
Job description

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 bring to market the first 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:

  • Contribute to the company's regulatory strategy for AI products in the medical sector

  • Support the CE Marking process for In Vitro Medical Devices, including artificial intelligence algorithms for medical diagnosis

  • Ensure conformity assessment processes and technical documentation meet EU regulations (MDR/IVDR/EU AI Act)

  • Verify declarations of conformity and technical documentation are complete and up-to-date

  • Implement and maintain effective post-market surveillance systems

  • Oversee necessary corrective and preventive actions according to quality management procedures

  • Act as the contact point for regulatory authorities on compliance matters

  • Ensure appropriate risk assessment and mitigation measures for all products

  • Review and evaluate product-related incidents and establish communication channels with authorities

  • Collaborate on health authorization applications and clinical studies supervision

  • Maintain regulatory competence and ensure staff training on requirements

  • Collaborate with the AI team to ensure products comply with the EU AI Act

  • Support regulatory audits, internal audits, and supplier evaluation meetings

Job requirements

  • University degree in Engineering, Medicine, Pharmacy, Law, or relevant scientific discipline

  • Minimum 2 years in regulatory affairs and quality management for medical devices

  • Strong understanding of EU MDR 2017/745 and IVDR 2017/746 regulations

  • Excellent analytical abilities, attention to detail, and communication skills

  • Experience in SaMD (Software as a Medical Device) regulation

  • Ability to interpret and apply regulatory requirements for AI systems in the medical sector

  • Advanced English and Spanish (verbal and written)

  • Ability to work in a fast-changing environment with multidisciplinary teams

  • Nice to have: Knowledge of emerging AI regulations in healthcare, especially the EU AI Act

All done

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