Hugo Leis Martínez, PhD

Senior QA/RA Expert - IVD Manager at MDx CRO
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Contact Information
us****@****om
(386) 825-5501
Location
Valencia, Valencian Community, Spain, ES
Languages
  • Español Native or bilingual proficiency
  • Inglés Professional working proficiency
  • Gallego Native or bilingual proficiency
  • Catalán Professional working proficiency

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Alejandro Villalba Abad

Trabajar con Hugo ha sido una de las experiencias más enriquecedoras que he podido tener a lo largo de mi vida laboral. Su elevada visión y capacidad organizativa hacía que hasta los procesos más complejos se tornasen fáciles de comprender. Destaca su alta implicación en cualquier tipo de tarea y posee una habilidad innata para comunicar y transmitir sus conocimientos. Maestro y mentor en mi andadura en el sector sanitario, ha sabido sacar lo mejor de mí en todos los aspectos. Más líder que jefe, pero sobre todo, compañero.

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Credentials

  • ISO 13485 Lead Auditor - Medical Devices
    BSI
    Nov, 2022
    - Nov, 2024
  • Good Clinical Practice
    The National Institute on Drug Abuse (NIDA)
    Mar, 2023
    - Nov, 2024

Experience

  • MDx CRO
    • Spain
    • Medical Device
    • 1 - 100 Employee
    • Senior QA/RA Expert - IVD Manager
      • Oct 2022 - Present

  • CEU Cardenal Herrera University
    • Spain
    • Higher Education
    • 700 & Above Employee
    • Guest Speaker
      • Jan 2017 - Present

      External lecturer in the Food Safety Master's program (Food Crisis Management) External lecturer in the Food Safety Master's program (Food Crisis Management)

  • AseBio - Asociación Española de Empresas Biotecnológicas
    • Spain
    • Biotechnology Research
    • 1 - 100 Employee
    • Health Area Head
      • Jan 2022 - Oct 2022

  • Sistemas Genómicos | member of SYNLAB
    • Spain
    • Biotechnology Research
    • 1 - 100 Employee
    • Regulatory Affairs and Quality System Manager
      • 2015 - Jan 2022

      Guarantee product and procedure conformity. Ensure compliance with current regulatory standards (In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746, ISO13485, ISO15189, ISO9001, ISO14001, and ISO17025). Responsible for global product registrations and informing the company of regulatory changes/advancements. Oversees product design, development, and introduction quality in close collaboration with R&D. Establishes the regulatory approach for new products in collaboration with clients and the R&D department.Implement the necessary compliance strategies and create and oversee compliance site programs. Ensure risk mitigation, negative regulatory exposure, and unfavorable business impact. Establish, implement, and analyze Quality key performance indicators (KPIs) to promote improvements. Manage audit readiness for authority, notifying bodies, customers, and internal audits. Show less

    • Laboratory Coordinator
      • Jan 2010 - Mar 2015

      Control all production steps, beginning with sample management and proceeding through complex analysis, interpretation, and reporting. Handling of customers and document and record control. Establishment and validation of novel assays working together on scientific initiatives. technical in charge of audits (ENAC ISO17025, AENOR ISO9001). to carry out internal audits Laboratory management of resources

  • Instituto Valenciano de Investigaciones Agrarias - ivia
    • Spain
    • Research Services
    • 1 - 100 Employee
    • Research Microbiologist
      • Jan 2008 - Dec 2009

      Conducting microbiology research project Conducting microbiology research project

  • Centro de Investigación Príncipe Felipe (CIPF)
    • Spain
    • Research Services
    • 100 - 200 Employee
    • Research Associate
      • Jan 2006 - Dec 2006

      Research project in molecular biology with animal models of disease (ectodermal dysplasia in rodents), employing cell culture techniques, experimental surgery in rodents, histology, transgenesis, molecular biology (PCR, DNA, RNA and protein extraction, immunoprecipitations, western blotting, Elisa, cloning, southern and northern, retrotransposition, EMSA), hospital environment sampling, etc. Research project in molecular biology with animal models of disease (ectodermal dysplasia in rodents), employing cell culture techniques, experimental surgery in rodents, histology, transgenesis, molecular biology (PCR, DNA, RNA and protein extraction, immunoprecipitations, western blotting, Elisa, cloning, southern and northern, retrotransposition, EMSA), hospital environment sampling, etc.

Education

  • Universidad Santiago de Compostela
    Doctorado, Biología molecular
    2000 - 2005
  • Universidade de Santiago de Compostela
    Licenciado, Veterinaria
    1994 - 1999
  • Universidad Rey Juan Carlos
    Director de Sistemas de Gestión de la Calidad
    2015 - 2015

Community

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