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José Miguel Jiménez Abarca

José Miguel Jiménez Abarca

Regulatory Affairs Intern

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location of José Miguel Jiménez AbarcaPuriscal, San Jose, Costa Rica

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  • Timeline

  • About me

    Biotechnology Engineer | Technological Institute of Costa Rica | Experience in Regulatory Affairs in the Medical Devices Industry | Knowledge in QMS, Six Sigma and LEAN Manufacturing

  • Education

    • Tecnológico de Costa Rica

      2021 - 2023
      Licenciatura Ingienería en Biotecnología

      • Quality Management Systems• Biotechnological production systems• Project management and soft skills• Final Graduation Project: Resource analysis for the start-up or implementation of the requirements introduced by the IVDR in companies of in vitro diagnostic medical devices class C.

    • Tecnológico de Costa Rica

      2017 - 2021
      Bachillerato Ingeniería en Biotecnología

      • Scientific research and development.• Molecular biology laboratory techniques• Familiar with clean room and laboratory good practices.• Sterilization and microbiological analysis techniques.

    • Tecnológico de Costa Rica

      2018 - 2021
      FORTALECIMIENTO DEL INGLÉS CONARE-TEC QUINCE NIVELES APROBADOS

  • Experience

    • CRx Life Sciences

      Jun 2022 - May 2023
      Regulatory Affairs Intern

      • Preparation and submission of regulatory documents to the Minister of health in Costa Rica• Supporting the preparation of FDA regulatory documents • Supporting the preparation of MDR regulatory documents• Time and movements study at the manufacturing process line.

    • BMA Group Global

      Aug 2023 - Nov 2023
      Quality System Specialist

    • Medtronic

      Nov 2023 - now
      Associate Quality System Specialist

  • Licenses & Certifications

    • Introduction to Medical Devices Industry and ISO 13485 Medical Devices

      School of Medical Devices - SMD
      Nov 2022

    • Auditorías a Sistemas de Calidad

      Tecnológico de Costa Rica
      Jun 2021

    • SYKES Academy B2 English Level Diploma

      SYKES Costa Rica
      Jan 2021

    • QMS Training for Medical Devices: FDA QSR and ISO 13485:2016

      Oriel STAT A MATRIX
      Mar 2024

    • SCRUM Fundamentals Certified

      VMEdu Inc.
      Mar 2021