Elena Lucano Email and Phone Number
Elena Lucano work email
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Elena Lucano personal email
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.
Veranex
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Quality And Regulatory Affairs ManagerVeranex Oct 2023 - PresentLausanne, Vaud, Switzerland -
Caraqa Program ManagerCaraqa Nov 2019 - Present -
Training Manager & Senior AssociateMedidee Nov 2019 - Oct 2023Lausanne Area, SwitzerlandLeader 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. -
Product ManagerInsilicotrials Jun 2017 - Nov 2019Trieste Area, ItalyProject 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. -
Internship TraineeIt'Is Foundation Oct 2015 - Feb 2016Zürich Area, SvizzeraDevelopment 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). -
Biomedical EngineerFda Apr 2013 - Feb 2016Silver Spring, Md, UsaRegulatory 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. -
TraineeIstituto Superiore Di Sanità Aug 2012 - Dec 2012Roma, ItaliaDesign 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. -
TraineeFondazione Santa Lucia Jul 2010 - Dec 2010Roma, ItaliaInternship 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
Elena Lucano Education Details
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PecbGeneral Data Protection Regulation -
Electrical, Electronic And Communications Engineering Technology/Technician -
110/110 Cum Laude -
102/110 -
Liceo Scientifico "A.Avogadro"95/100
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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ELENA MARINA lucano chavez
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