formato europeo per il curriculum vitae

PERSONAL INFORMATION
Name
Address
Telephone
E-mail
Nationality
Place and Date of birth
WORK EXPERIENCE
Dates
Occupation or position held
Main activities and responsibilities
Name and address of employer
Type of business or sector
Dates
Occupation or position held
Main activities and responsibilities
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Occupation or position held
Main activities and responsibilities
Name and address of employer
Type of business or sector
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Name and address of employer
Curriculum Vitae of Daniela Seneca
SENECA DANIELA
VIA PESCOSOLIDO 46, INT.25,
00158 ROMA
+39 3466447160
+39 0664469017
[email protected]
Italian
Rome 17 / 10 / 1981
May 2013 – present
Medical device expert - auditor at the Italian MOH
- Audits at Italian medical device manufacturers and notified bodies
- Clinical studies evaluations
- EUDAMED data upload and support in the EU and IMDRF working groups activity
- Audits follow-up, medical device vigilance and surveillance, HTA
- Regulatory affairs (qualification and classification, software as medical device, quality system
assessment, risk management, technical documentation/ harmonised standards, devices
utilising tissues of animal origin)
- National Medical Device Expert in the joint audits of notified bodies with the European
Commission
ITALIAN MINISTRY OF HEALTH
Via Giorgio Ribotta 5, 00144 Roma (www.ministerosalute.it)
Healthcare
January 2011 – present
Clinical and Regulatory Consultant – self employed
April 2011 – April 2013: assisting Expedia MRCC S.r.l in registration of biocidal products
October 2011: training on vigilance on medical devices and Competent Authority notification of
clinical studies for Otsuka Pharmaceutical Italy S.r.l
October 2011 – April 2013: Ultrasound Application Specialist for BioliveGroup S.r.l. (Italian
distributor of ALPINION ultrasound systems) and registration of their products into the Italian
Ministry of Health databank
March 2012: lecturer at the ALTEMS course on “Management of Bio-medical and Technological
companies”, Università Cattolica del Sacro Cuore
June-July 2013: lecturer at the course “Designing a medical device”, Centro Europeo di Studi
Manageriali
February 2010 – December 2010
Medical device expert - auditor at the Italian MOH
Medical Device Vigilance and Surveillance, 15 audits at Italian medical device manufacturers (2
as auditor team leader), Clinical Studies Evaluation, technical files evaluation, decree draft
review
ITALIAN MINISTRY OF HEALTH
Via Giorgio Ribotta 5, 00144 Roma (www.ministerosalute.it)
Healthcare
October 2008 – February 2010
Clinical and Regulatory Assistant
Medical device registration on the Italian Ministry of Health databank, Regulatory, EU Medical
Device Directives, Medical Device Vigilance, Clinical Studies in Europe (Clinical Trial
submission to Competent Authorities and Ethics Committees, study documents drafting and
review, approval process, CRO services, monitoring), CE marking, US 510k, Quality Systems
DONAWA CONSULTING SRL
Piazza Albania10, 00153 Roma (www.donawa.com)
"Autorizzo il trattamento dei dati personali ai sensi del D.Lgs. 196/2003"
Le dichiarazioni contenute in questo curriculum sono rese ai sensi dell’art.47 del D.P.R.445/2000
Type of business or sector
Dates
Occupation or position held
Main activities and responsibilities
Name and address of employer
Type of business or sector
Dates
Occupation or position held
Main activities and responsibilities
Name and address of employer
Type of business or sector
Dates
Occupation or position held
Main activities and responsibilities
Name and address of employer
Type of business or sector
Contract Research Organization, Consultancy on Regulatory and Quality Systems
August 2006 – September 2008
Technology Development Engineer
Early stage technology development, proof of concept, modelling, prototyping, IP
commercialization and management, patent drafting, patent and market searches, product
development
Technology from Ideas Ltd., 22 Canal Walk, Park West, D12, Dublin
(www.technologyfromideas.com)
Research & Development
From September 2007 to December 2007 (evenings)
Volunteer at the Depaul Trust for the Bluebell project – hostel for disabled homeless people
Providing quality support to residents with handicaps, mobility issues and drugs and alcohol
addiction to motivate them and fulfil their potential
The Depaul Trust Irl Ltd, 18 Nicholas St, Christchurch, D8, Dublin
Social services
June – July 2006
Training in the Laboratory of Biomedical Robotics & EMC, Campus Bio-Medico
Further development and experiments on the catching platform of my final project; testing and
cataloguing of the assistive, adaptive, and rehabilitative devices available in the hospital
University "Campus Bio-Medico", via Álvaro del Portillo, 21 - 00128 Roma
Assistive and Rehabilitation Technology
EDUCATION AND TRAINING
• Dates (from – to)
• Name and type of organization
• Principal subjects/occupational
skills covered
February 2011 – December 2011
Università Cattolica del Sacro Cuore
Master in Health Technology Assessment (medical, economic, social and ethical evaluations
of medical technology in health care)
• Dates (from – to)
• Name and type of organization
• Principal subjects/occupational
skills covered
6-10 July 2009, 40 hours + exam
ANGQ (Associazione Nazionale Garanzia della Qualità)
“Auditor team leader of Quality management systems” (ISO 9001 and 19011, ISO/IEC
17000 series) qualified CEPAS (registration n.4, forms SH124 & SH125)
• Dates (from – to)
• Name and type of organization
28 Nov 2008
DONAWA CONSULTING SRL
• Principal subjects/occupational
skills covered
CRA (Clinical Research Associate) Training
MD directives, US and European differences, Drugs vs Devices, Vigilance
• Dates (from – to)
• Name and type of organization
providing education and training
June 2008
Product Development & Management Association (UK & Ireland)
NPDP (New Product Development Professional) workshop training
• Dates (from – to)
• Name and type of organization
providing education and training
• Principal subjects/occupational
skills covered
November 2006
Innovator
Patents, Copyright & Licensing
Gain an understanding of why Intellectual Property is so critical for all companies and how to
manage IP assets, understand the different types of IP and their relevance to business, practical
insights on the different systems, costs and the strategic use of IP as a competitive business tool
• Dates (from – to)
• Name and type of organization
providing education and training
September 2006
Trigraph Professional Services Ltd
Principles of Project Management
Curriculum Vitae of Daniela Seneca
"Autorizzo il trattamento dei dati personali ai sensi del D.Lgs. 196/2003"
Le dichiarazioni contenute in questo curriculum sono rese ai sensi dell’art.47 del D.P.R.445/2000
• Principal subjects/occupational
skills covered
• Dates (from – to)
• Name and type of organization
• Faculty
• Title of qualification awarded
Define a project and its associated success factors, produce Work Breakdown Structures,
undertake project estimation, demonstrate an understanding of Critical Path Analysis, define an
administrative framework for Project Control, identify team building and management issue
2004-2006
University "Campus Bio-Medico" of Rome
Engineering
Master’s degree in Biomedical Engineering (102 / 110) with the project: “Mechatronic
System and experimental protocol for human arm impedance measures during catching tasks”
(Prof. E.Guglielmelli, Ing. L.Zollo)
• Dates (from – to)
• Name and type of organization
providing education and training
• Principal subjects/occupational
skills covered
September 19-23, 2005
IURS-5th International UJI Robotics School
First European Summer School on Neurobotics, Benicàssim, Spain
30 hours of invited lectures, practical work and group discussions on topics related to the
interplay between robotics and neuroscience
• Dates (from – to)
• Name and type of organization
• Title of qualification awarded
• Principal subjects/occupational
skills covered
July 07, 2004
Cisco Academy Training Centre
IT Essentials II: Network Operating Systems
Diagnose, troubleshoot and resolve common Network Operating System problems (Windows
2000 Professional and Linux)
Design and configure basic security network solutions
• Dates (from – to)
• Name and type of organization
• Faculty
• Title of qualification awarded
2000-2004
University "Campus Bio-Medico" of Rome
Engineering
Bachelor’s degree in Biomedical Engineering (106 / 110) with the project: “Materials for
clever systems: artificial muscles and applications of IPMC and hydrogel” (Prof. M.Trombetta)
• Dates (from – to)
• Name and type of organization
• Principal subjects
• Dates (from – to)
• Name and type of organization
• Title of qualification awarded
June-August 1999
"Saint Ignatius" College, Adelaide, Australia
Science, Biology, Australian History and Literature, English
1995-2000
High School "Liceo Scientifico Statale B.Croce" in Rome
Italian High School Certificate (98/100)
PUBLICATIONS
“Dispositivi Medici – Aspetti Regolatori e Operativi”, dgFDM Italian Ministry of Health (2010)
PERSONAL SKILLS
MOTHER TONGUE
ITALIAN
OTHER LANGUAGES
• Reading skills
• Writing skills
• Verbal skills
• Presentation skills
ENGLISH
Excellent
Excellent
Excellent
Excellent
TECHNICAL SKILLS AND COMPETENCES
Curriculum Vitae of Daniela Seneca
FRENCH
Very Good
Elementary
Very Good
Elementary
Auditor and consultant on Quality Systems (ISO 9001, 19011, 13485) and medical device CE
marking
Regulatory affairs (qualification and classification of medical devices, software as medical
device, risk management, technical documentation/ harmonised standards, clinical evaluation,
devices utilising tissues of animal origin)
Network Operating Systems, Windows & Office, Matlab, Simulink, CAD (Solidworks,
CosmosMotion), C, Assembler (basic level), Tensile testing machine & testXpert Software
Patents drafting, market searches & technology transfer
Project management (Microsoft project) and Product development
Clinical studies on pharmaceuticals and medical devices
"Autorizzo il trattamento dei dati personali ai sensi del D.Lgs. 196/2003"
Le dichiarazioni contenute in questo curriculum sono rese ai sensi dell’art.47 del D.P.R.445/2000
OTHER:
CHARTERED ENGINEER ROME 2007 (ABILITAZIONE ALLA PROFESSIONE DI INGEGNERE,SEZIONE A
CLASSE 26/S)
IEEE MEMBER SINCE 2006
MEMBER OF ITALIAN “ORDINE DEGLI INGEGNERI”, AIIC AND EC INITIATIVE “YOUNG GASTEINER”
RED CROSS VOLUNTEER SINCE MARCH 2015
FULL DRIVING LICENCE (B)
BIOMEDICAL ENGINEERING:
MAIN SUBJECTS
MAIN PROJECTS FOLLOWED:
HOBBIES & INTERESTS:
Curriculum Vitae of Daniela Seneca
Mathematical Analysis I, Antropology, Chemistry, Economy, Physics I, Computer Science,
Geometry, Biomaterials, Anatomy And Physiology, Biology, Ethics, Physics Ii, Electrical
Engineering, Mechanics, Sensors And Trasducers, Mathematical Analysis Ii, Data Base,
Electromagnetism Phenomena, Numerical Elaboration Of Biomedical Signals, Electronics,
Automatic Controls, Biomedical Instrumentation, Biomechatronics, Dinamics Of Complex
Biological Systems, Electromagnetic Compatibility, Imaging, Electromagnetic Interation,
Mathematical Analysis Iii, Electronics Ii, Rehabilitation Engineering, Telematica, Robotics,
Artificial Organs
Renewable energy (ocean and tidal power), E-beam sterilization, MRI head positioning,
Hydraulic braking, Sterling engine, Nanocomposites, Spinal cage, MRI guided focused
ultrasound system, Exoskeleton, Vagal nerve stimulation device, needles conformity
assessment
Music (rock, can play sax & piano), poetry, volunteering, cinema, cooking/eating, travelling,
skiing, scuba diving, volleyball in the University team
"Autorizzo il trattamento dei dati personali ai sensi del D.Lgs. 196/2003"
Le dichiarazioni contenute in questo curriculum sono rese ai sensi dell’art.47 del D.P.R.445/2000