Colette Charbonnier

Colette Charbonnier Email and Phone Number

Product, Quality and Regulatory Manager - Medical devices - Software development - PhD @ Ekinnox
france
Colette Charbonnier's Location
Greater Nice Metropolitan Area, France
Colette Charbonnier's Contact Details

Colette Charbonnier work email

Colette Charbonnier personal email

n/a
About Colette Charbonnier

Colette Charbonnier is a Product, Quality and Regulatory Manager - Medical devices - Software development - PhD at Ekinnox. She possess expertise in medical devices, clinical research, biomedical engineering, product development, pharmaceutical industry and 17 more skills. She is proficient in Allemand and Anglais.

Colette Charbonnier's Current Company Details
Ekinnox

Ekinnox

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Product, Quality and Regulatory Manager - Medical devices - Software development - PhD
france
Website:
ekinnox.fr
Employees:
7
Colette Charbonnier Work Experience Details
  • Ekinnox
    Product, Quality And Regulatory Manager
    Ekinnox Jan 2019 - Present
    Nice Area, France
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  • Self-Employed
    Consultant
    Self-Employed May 2018 - Dec 2018
    Nice Area, France
    Ensure consulting activities for medical devices companies. Skills areas: design control and regulatory affairs.
  • Zimmer Biomet
    R&D Project Manager - System Engineer
    Zimmer Biomet Jun 2017 - Apr 2018
    Montpellier Area, France
    Responsible for the development of surgical robots according to change and design control proceduresChange requests definitionDevelopment monitoring with R&D (hardware and software), production and regulatory affairs teamsDHF (Device History file) constitutionRequirements managementProject management
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  • Median Technologies
    Senior Product Development Manager
    Median Technologies 2005 - 2016
    Responsible for defining new clinical software applications for radiologists and for managing their development as active medical devices Followed and improved a design control procedureElaborated vision documents to describe ideas of new products and demonstrated their valueDefined the product requirements according to the stakeholders requests and the regulatory strategyBuilt proofs of concept and performed demonstrations to get internal and external stakeholders acceptancePrioritized the development of the product requirements according to the R&D department capabilities and the company strategyConducted validation programs in collaboration with cliniciansCollaborated with Key Opinion Leaders in radiologyEnsured the completion of the technical files required for the CE markingSupervised the production of the user documentationWrote white papers, brochures and data sheets in collaboration with the marketing department
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  • Allergan (Corneal Industries)
    R&D Project Manager
    Allergan (Corneal Industries) 2001 - 2005
    In charge of improving the performances of a system for cataract surgery (Phacoemulsifier).Improved the manufacturing process, replaced obsolete technologies and reduced costsKeep the technical file up-to-date for the CE marking
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  • Edap-Tms
    R&D Project Manager
    Edap-Tms 1997 - 2001
    Ensured the development of an innovative medical device for cancer treatment by focused ultrasounds under Magnetic Resonance Imaging (MRI) guidance.Defined the prototype in collaboration with SIEMENS AG as well as scientific and medical partnersBuilt prototypes with a team of technicians and engineers in electronics, mechanics and informaticsBegan a clinical trial to get the regulatory agreement to market the device (first patient treated in Europe)Elaborated and coordinated a European project in research and development
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  • Cea
    Design Engineer
    Cea 1995 - 1997
    Validated an eye movement measurement system to study space illness in the frame of a European Space Agency (ESA) projectProvided a comprehensive validation report covering the safety and effectiveness requirements for a spacecraft based system
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Colette Charbonnier Skills

Medical Devices Clinical Research Biomedical Engineering Product Development Pharmaceutical Industry Biotechnology Medical Imaging Clinical Trials Lifesciences Project Management Regulatory Affairs Oncology Fda Clinical Development Gmp R&d Validation Responsable Produit Conception De Produit Secteur Pharmaceutique Radiologie Iso 13485

Colette Charbonnier Education Details

Frequently Asked Questions about Colette Charbonnier

What company does Colette Charbonnier work for?

Colette Charbonnier works for Ekinnox

What is Colette Charbonnier's role at the current company?

Colette Charbonnier's current role is Product, Quality and Regulatory Manager - Medical devices - Software development - PhD.

What is Colette Charbonnier's email address?

Colette Charbonnier's email address is co****@****ies.com

What schools did Colette Charbonnier attend?

Colette Charbonnier attended Institut Polytechnique De Grenoble, Université Joseph Fourier (Grenoble I).

What skills is Colette Charbonnier known for?

Colette Charbonnier has skills like Medical Devices, Clinical Research, Biomedical Engineering, Product Development, Pharmaceutical Industry, Biotechnology, Medical Imaging, Clinical Trials, Lifesciences, Project Management, Regulatory Affairs, Oncology.

Who are Colette Charbonnier's colleagues?

Colette Charbonnier's colleagues are Baptiste Fosty, Mathilde Maccario, Nicolas Maire, Colette Charbonnier, Nancy Issa.

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