Francesca Marello
Regulatory Affairs Specialist at Lima Corporate- Claim this Profile
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Inglese Professional working proficiency
Topline Score
Bio
Experience
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Lima Corporate
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Italy
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Medical Equipment Manufacturing
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700 & Above Employee
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Regulatory Affairs Specialist
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Jun 2023 - Present
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Junior Regulatory Engineer
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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
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Connect Informatics S.r.l
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Italy
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IT Services and IT Consulting
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1 - 100 Employee
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Product Specialist
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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
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REJOINT
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Italy
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Medical Equipment Manufacturing
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1 - 100 Employee
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Stagista
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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
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UniTS Racing Team
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Italy
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Civic and Social Organizations
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1 - 100 Employee
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Member of Business and Logistic division
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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.
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Diverse agenzie
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Trieste, Italia
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Hostess
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Jul 2017 - Mar 2018
Lavoro occasionale come Hostess/Promoter Lavoro occasionale come Hostess/Promoter
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Education
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Università degli Studi di Trieste
Laurea Magistrale LM in Ingegneria Biomedica, Ingegneria Clinica curriculum Biomedica -
Università degli Studi di Trieste
Laurea Triennale in Ingegneria dell'Informazione, Ingegneria dell'informazione curriculum Biomedica -
Liceo Classico Francesco Petrarca
Diploma di liceo classico, 80/100 -
Liceo Classico Leone XIII