María Salvador Bernáldez

Regulatory Affairs Manager, PhD | MedTech | Regulatory Intelligence | Post-market surveillance | MDR

Madrid, Community of Madrid, Spain

About

From Academia to Industry I've discovered my new passion for Regulatory world, firstly with MDR and afterwards with regulations of other parts of the world. Passionate about regulatory intelligence and  strategy in the wide environment of medical devices. Always willing to learn new features or points of view in the increasingly stringent markets all over the world. I'm a highly collaborative person with the ability to manage different projects in parallel with commitment and responsibility. My previous jobs allow me to develop abilities as versatility, communication, coordination, organisation and working in-group and independently.

Experience

  • Avizor Eye Care Solutions (8 yrs 5 mos)
    • Regulatory Affairs Manager
      Sep 2021 - Present · 4 yrs 10 mos

    • US & LATAM Regulatory Affairs Officer
      Feb 2021 - Sep 2021 · 8 mos

      US FDA - pre-submission meeting, 510k, 513g. LATAM - ANVISA, COFEPRIS, INVIMA... CHINA - NMPA

    • Regulatory Affairs Technician
      Feb 2019 - Feb 2021 · 2 yrs 1 mo

      CE Conformity assessment - MDD/MDR Post-Market surveillance (PSUR, CER, PMCF) SOPs and Technical File management. US FDA

  • Spanish National Center for Biotechnology (Madrid y alrededores, España)
    • Postdoctoral Research Scientist at Immunology and Oncology Department
      Jul 2012 - Mar 2017 · 4 yrs 9 mos

      Immunology, Cell and Molecular Biology. - Finding new research lines - Scientifical Writting - Data Analysis - Postgraduate students management (project accessibility, goal setting and supervision). Research lines: Disecting the role of p38α and p38β in T cell effector function. Regulation of differention during autoimmunity. Supervisor: Jesús M. Salvador Sánchez

    • PhD Student at Immunology and Oncology Department
      Feb 2006 - Jul 2012 · 6 yrs 6 mos

      Immunology, Cell and Molecular Biology. -Human samples and Mouse experimental procedures. - Primary cell purification, T cell functional assays ( cell cycle, differentiation, apoptosis). Flow cytometry. - Data presentation and analysis. Research lines: Role of Gadd45b and p38 MAPK in thymic selection and T cell function. Alternative p38 activation pathway in autoimmune diseases (Rheumatoid Arthritis, Lupus …). Supervisor: Jesús M. Salvador Sánchez

  • Research assistant at Hematology Department at Hospital Clínico San Carlos
    Jun 2004 - Feb 2006 · 1 yr 9 mos

    Molecular Biology and Hematology. - DNA/RNA extraction, PCR, DNA sequencing. - Southern blot. - Cloning. Minipreps. - Data presentation and analysis. Research lines: Association between 16189 mitochondrial variant and haemochromatosis. Regulation of Gfi1-b gene during normal an d pathological erythropoiesis. Molecular Biology in the diagnosis of haematological diseases (Fanconi Anaemia, Thalassemia, Polycythemia vera…) Supervisor: Dr. Ana M. Villegas Martínez

  • Traineeship at Faunia Nature Park. at FAUNIA
    Jul 2003 - Sep 2003 · 3 mos

    Animal caretaker and park guide.