Mónica Ropero Díaz

at Health in Code Group
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Madrid Metropolitan Area, ES

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Bio

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Experience

    • Spain
    • Biotechnology Research
    • 100 - 200 Employee
      • Jan 2021 - Present

      • Jan 2021 - Present

      • Jan 2021 - Present

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • QARA Specialist, EU MDR
      • Jan 2018 - Jul 2021

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Business Quality Specialist
      • Jul 2017 - Jan 2018

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • QARA Specialist
      • Jul 2016 - Jul 2017

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Quality and Regulatory Affairs
      • Apr 2014 - Apr 2016

      As a key player in a highly regulated industry, GE Healthcare puts a strong emphasis on Quality and Regulatory Affairs. I had the privilege of joining their team of highly motivated employees and to carry out important responsibilities; my primary functions in the past 2 years can be divided in two main categories: Quality Management System: • Reviewing Quality Management System Procedures • Participating in the Corrective and Preventive Action (CAPA) process • Internal audit coordination • Giving internal training on Quality Management Systems • Monitoring and reporting on training metrics • Participating in upper management review meetings Medical Devices products management: • Control, management and release of Medical Devices products • Management of CE Certificates • Monitoring and coordination through enterprise quality management software such as Trackwise and MyWorkshop • Participating in internal and external audits (GMED) as provided in ISO 13485. • Main point of contact for communication of corrective action to the Spanish Agency of Medicines and Medical Devices (AEMPS) • Management of health alerts at the Autonomous Community level in Spain Show less

    • Laboratory technician
      • Feb 2013 - Nov 2013

      As a recent graduate, I was given the opportunity to carry out a research stay at this prestigious center in Madrid, Spain. I joined the Environmental department of the Ecotoxicology unit for 9 months and during that time I was able to further develop the skills and knowledge acquired during my Biology studies. My main responsibilities were: • Carrying out in vitro techniques and procedures with established cell lines from vertebrates, with the main goal of supporting key lines of research. • Routine maintenance of cell lines and biological assays for the evaluation of the toxicity of certain chemical substances in the aquatic environment. My work was part of a project entitled “Ecotoxicidad de Nanopartículas metálicas presentes en lodos de depuradoras” RTA 2010-00018-00-00. • I communicated my results and findings in English and I featured as one of the authors in the resulting paper on Exotoxicity entitled “Ecotoxical Evaluation of sewage sludge contaminated with ZnO nanoparticles”. Revista Nano Ostrava. Junio 17-20. 2013. Show less

    • United States
    • Environmental Services
    • 1 - 100 Employee
    • Environmental Anacostia Watershed Society Internship
      • Jun 2013 - Sep 2013

      The Anacostia Watershed Society was founded in 1989 and over the past 20 years, has carried out efforts in environmental education, stewardship, and recreation, as well as engaging the community through public affairs. As an intern/volunteer, I was involved in a wide range of activities: • Restoration of the Anacostia River, Watershed and surrounding areas, from Washington D.C. to Prince George’s county (U.S.A). • Conducting a wetland plant survey as part of a study to find removal techniques to control Phragmites australis, conducting invasive plant control activities, tree maintenance tasks, installing goose exclosures as part of a wetland restoration project in the tidal portion of the Anacostia River • Public outreach and awareness raising through directed activites. I communicated solely in English and sometimes acted as a mediator for the staff and the Spanish-speaking population of Washington D.C. and surrounding counties in Maryland. Show less

    • Biotechnology Research
    • 1 - 100 Employee
    • Research Intern
      • Oct 2012 - Jul 2013

      I joined the anthropology and geology department as a research intern to carry out the research for my final year dissertation in Biology. I was trained in the use of a Scanning Electron Microscope in low vacuum as well as highly specialized software (Microwear 4.02.) to study microphotographs. The highly technical aspect of this project inspired me to pursue a Master’s degree in Biotechnology and, later on, to become involved in health care product management. I joined the anthropology and geology department as a research intern to carry out the research for my final year dissertation in Biology. I was trained in the use of a Scanning Electron Microscope in low vacuum as well as highly specialized software (Microwear 4.02.) to study microphotographs. The highly technical aspect of this project inspired me to pursue a Master’s degree in Biotechnology and, later on, to become involved in health care product management.

Education

  • Aliter, Escuela Internacional de Negocios
    Master´s degree in Biotecnology, Biotecnology
    2013 - 2014
  • Universidad Autónoma de Madrid
    Degree in Biology, Biology, general
    2006 - 2012
  • CESIF
    Master en Farmacia Industrial - REGISTRO DE MEDICAMENTOS Y REGULATORY AFFAIRS, Ciencias farmacéuticas/Farmacología
    2019 -

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