Francesca Marello

Regulatory Affairs Specialist at Lima Corporate
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Contact Information
us****@****om
(386) 825-5501
Location
Italy, IT
Languages
  • Inglese Professional working proficiency

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Bio

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Experience

    • Italy
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Specialist
      • Jun 2023 - Present

    • Junior Regulatory Engineer
      • Jun 2021 - Jun 2023

      Registration of Class III and II orthopeadic implants and software as medical device.Knowledge of regulatory affairs of Europe, FDA, Health Canada.Knowledge of the Medical Device Regulation MDR 2017/745Preparing technical documentation for the registration of class III and class II medical devices (both implants and software) for US, Canada and EU (according to MDR 2017/745)Taking part in projects team for the development of new products, in compliance with the regulatory requirements of each CountryAttending audit of Notified Bodies or Competent Authorities Show less

    • Italy
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Product Specialist
      • Mar 2021 - May 2021

      - Implementation of the digital Health Record comprising of clinical, administrative and organizational processes - Initialization of informatic systems in hospitals, nursing homes, clinics of physiotherapy, elderly care homes, outpatient clinics - Realization of tablet based digital forms used by medical professionals - Configuration of operating processes in regards to patient care - Analysis and definition of health, administrative and organizational processes, in order to produce structured data - Implementation of data presentation systems related to quality processes, business intelligence and pattern identification, aimed at the historical analysis or the statistics prediction - Primary and secondary costumer support (demonstrative and system) - Production of technical documents for the use of the software and configuration instruments Show less

    • Italy
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Stagista
      • Jun 2020 - Dec 2020

      Internship in conjunction with the thesis at the company Rejoint S.r.l THESIS: “EBM image processing and printing process control: development of a defect detection system using images from the Arcam LayerQam” During this experience I worked as a trainee student in the department of R&D, which allowed me to consolidate my skills in developing a quality observation tool based on deep learning technology for 3D-printed prosthetic devices. Thanks to this experience, I was able to further develop my problem solving and adaptability skills: due to the pandemic, most of the project and the communication with other collaborators has become mostly digital. Show less

    • Italy
    • Civic and Social Organizations
    • 1 - 100 Employee
    • Member of Business and Logistic division
      • Nov 2019 - Oct 2020

      Being a member of UniTs Racing Team in the Business and Logistic department in the International Formula SAE project taught me how to work in a proactive and organized way but at the same time to collaborate in a team through accurate communication and the prompt sharing of information. Being a member of UniTs Racing Team in the Business and Logistic department in the International Formula SAE project taught me how to work in a proactive and organized way but at the same time to collaborate in a team through accurate communication and the prompt sharing of information.

  • Diverse agenzie
    • Trieste, Italia
    • Hostess
      • Jul 2017 - Mar 2018

      Lavoro occasionale come Hostess/Promoter Lavoro occasionale come Hostess/Promoter

Education

  • Università degli Studi di Trieste
    Laurea Magistrale LM in Ingegneria Biomedica, Ingegneria Clinica curriculum Biomedica
    2017 - 2020
  • Università degli Studi di Trieste
    Laurea Triennale in Ingegneria dell'Informazione, Ingegneria dell'informazione curriculum Biomedica
    2012 - 2017
  • Liceo Classico Francesco Petrarca
    Diploma di liceo classico, 80/100
    2010 - 2012
  • Liceo Classico Leone XIII
    2007 - 2010

Community

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