Elena Lucano

Elena Lucano Email and Phone Number

Sr. Manager Quality & Regulatory Affairs | CDPO | Regulatory Science | Training Manager | Employ Engagment | PhD, Biomedical Engineer @ Veranex
Elena Lucano's Location
Morges, Vaud, Switzerland, Switzerland
Elena Lucano's Contact Details

Elena Lucano work email

Elena Lucano personal email

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About Elena Lucano

Leader and team member of projects supporting MedTech clients on the compliance with European and US regulatory requirements. Project leader on several projects supporting MedTech companies achieving their compliance with the European Data Privacy Legislations. Training Manager of the International CARAQA Training Network and responsible of the internal company LMS.Versatile experiences on modeling and simulations, laboratory and bench testing of medical devices conforming to international standards. Experience in regulatory science oriented to Pre-Market research. 6-years experience in computational modeling and measurements of medical devices compatibility with Magnetic Resonance Imaging (MRI). Well acquainted project management skills managing complex projects with multiple international collaborators. Great team player.

Elena Lucano's Current Company Details
Veranex

Veranex

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Sr. Manager Quality & Regulatory Affairs | CDPO | Regulatory Science | Training Manager | Employ Engagment | PhD, Biomedical Engineer
Elena Lucano Work Experience Details
  • Veranex
    Quality And Regulatory Affairs Manager
    Veranex Oct 2023 - Present
    Lausanne, Vaud, Switzerland
  • Caraqa
    Caraqa Program Manager
    Caraqa Nov 2019 - Present
  • Medidee
    Training Manager & Senior Associate
    Medidee Nov 2019 - Oct 2023
    Lausanne Area, Switzerland
    Leader and team member of projects related to regulatory compliance and quality assurance for EU and US. Developed several regulatory pathways for EU and US certification of MD and SaMD. Supported the development of QMS for system accreditation accordingly to ISO 13485 and 21 CFR 820. Project leader for compliance of MedTech companies with the General data Protection requirements. Subject Matter Expert for education on US regulatory landscape for medical devices and for European data privacy legislations. Training manager in charge of the organisation and management of the CAS CARAQA Training programs running throughout Europe, and responsable of the internal Learning Management System.
  • Insilicotrials
    Product Manager
    Insilicotrials Jun 2017 - Nov 2019
    Trieste Area, Italy
    Project leader of the NuMRis tool for compatibility assessment of medical devices with MRI scanner: bringing it form the initial design to its market release (within the cloud service platform InSilicoTrials.com). Active developer of the NuMRis tool engine generating python scripting for computer model automatization. Responsible for the market research and computational tools collection for the company radiology division. Marketing and research aimed to collect SaMDs for personalised medicine. Active engagement and communication with the principal sector stakeholders. Responsible for the company presentation design, and web analytic monitor. Participation in the development of the company QMS accordingly to ISO 13485 and IEC 62304.
  • It'Is Foundation
    Internship Trainee
    It'Is Foundation Oct 2015 - Feb 2016
    Zürich Area, Svizzera
    Development of novel experimental testing methods for safety assessment of implantable medical devices during MRI exposure. Bench testing of medical devices using robot technologies with high-precision near-field probings. Research activities on the reliability assessment of international standards testing method definition s(i.e., IEC 60601-2-33).
  • Fda
    Biomedical Engineer
    Fda Apr 2013 - Feb 2016
    Silver Spring, Md, Usa
    Regulatory science research activities for the Pre-Market evaluation of medical devices in the regulatory submission process. Development of computational models for clinical research using several FDTD and FEM computer software platforms. Research on computational human body models for the assessment of personalised medicine for MRI exposition studies. Use of the Verification, Validation and Uncertainty Quantification (VV\&UQ) procedure for the developed computer models. Application of several international standards directives in computer models development process (e.g., ASTM F2182 and TS ISO 10974 standards). Research activity results referenced in the 2018 ASME V\&V40 standard. Leader of a projects involving several international collaborators.
  • Istituto Superiore Di Sanità
    Trainee
    Istituto Superiore Di Sanità Aug 2012 - Dec 2012
    Roma, Italia
    Design and development of provocative testing procedure and tools for the assessment electromagnetic interference of custom radiofrequency identification (RFID) antennas on commercial pacemakers. Participation in projects for the impact analysis of MRI, WiFi and RFID on laboratory and hospital analytics equipment.
  • Fondazione Santa Lucia
    Trainee
    Fondazione Santa Lucia Jul 2010 - Dec 2010
    Roma, Italia
    Internship for Bachelor degree achievement in Clinical Engineering at the “Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS Santa Lucia” (via Ardeatina 306, 00142 Roma, Italia) in the laboratory of Neurophysiopathology.Principal subjects/occupational skills gained: Ability on recording and processing EEG signals in the Brain-Computer Interface (BCI) context.

Elena Lucano Skills

Matlab Computational Modeling Electromagnetics Simulations Mri Biomedical Engineering Rfid+ Bci Fdtd Remcom Xfdtd Semcad X Sim4life Photoshop Immagini Medicali Imaging A Risonanza Magnetica Simulazioni Elaborazione Immagini Microsoft Office Ingegneria Biomedica Labview C Strumenti Medicali Elaborazione Del Segnale Ricerca C++ Ricerca E Sviluppo Medical Devices Microsoft Excel Research Signal Processing Medical Imaging Image Processing Research And Development Product Management Project Management English U.s. Food And Drug Administration Wordpress Proto.io Mailchimp Google Analytics

Elena Lucano Education Details

Frequently Asked Questions about Elena Lucano

What company does Elena Lucano work for?

Elena Lucano works for Veranex

What is Elena Lucano's role at the current company?

Elena Lucano's current role is Sr. Manager Quality & Regulatory Affairs | CDPO | Regulatory Science | Training Manager | Employ Engagment | PhD, Biomedical Engineer.

What is Elena Lucano's email address?

Elena Lucano's email address is el****@****dee.com

What schools did Elena Lucano attend?

Elena Lucano attended Pecb, Sapienza Università Di Roma, Università Degli Studi Di Roma 'la Sapienza', Sapienza Università Di Roma, Liceo Scientifico "a.avogadro".

What skills is Elena Lucano known for?

Elena Lucano has skills like Matlab, Computational Modeling, Electromagnetics, Simulations, Mri, Biomedical Engineering, Rfid+, Bci, Fdtd, Remcom Xfdtd, Semcad X, Sim4life.

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