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Patricia E.

QARA Manager
1 recommendation
  • Suggested rate
    €750 / day
  • Experience8-15 years
  • Response rate100%
  • Response timeA few days
The project will begin once you accept Patricia's quote.
Location and workplace preferences
Location
Paris, France
Remote only
Primarily works remotely
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Patricia in a few words
Je suis responsable qualité et réglementaire spécialisée dans l’accompagnement de Startups et TPE dans l’élaboration de projets de certification. J’ai débuté dans le secteur agroalimentaire et je suis actuellement spécialisée dans le marquage CE des DM logiciels IA.

Je suis dynamique et enthousiaste, mes deux meilleures armes pour relever vos défis !
Experience
  • Apneal
    Quality and Regulatory Affairs Manager
    October 2022 - Today (2 years)
  • AZmed
    QARA Manager
    February 2020 - September 2022 (2 years and 7 months)
    Île-de-France, France
    ISO 13485 Certification project from scratch
    - Implementation of the QMS : writing of all the qms documentation (procedure, registers, forms, etc..)
    - Preparation and handling of internal and certification audits
    - Renewal of the certificate through surveillance audits
    - Follow up and maintain of the QMS compliance Transitioning from Directive 93/42 /CEE to MDR 2017/745
    - Writing and updating of the Technical files based on GSPR (Class Ia to Class IIa)
    - Writing of eIFU based on Regulation 207/2012
    - Writing and updating of the design files based on IEC 62304 and 82304
    - Implementation of Verification and validation process of all the versions released
    - Implementation of Usability testings
    - Implementation of a risk management process based on ISO 14971:2019
    - Implementation of a Vigilance process based on Meddev guidances
    - Implementation of Post market Surveillance and Post Market Clinical Surveillance processes Clinical process according to MDR 2017/745
    - Writing of the Clinical evaluation reports
    - Litterature review and summary European and international registrations
    - Writing of registration dossier based on each countries registration requirements
    - Contact with Authorised representatives FDA certification project
    - Implementation of all the applicable FDA Guidances for Computer assisted devices
    - Writing of Presubmission files
    - Preparation and handling of FDA meetings
    - Writing the 510k dossier based on predicate
    - Preparation and validation eCopys
    - Support in preparation of the Clinical Study: MRMC study with US partner MDSAP certification project
  • EFOR
    Consultante Qualité Dispositifs médicaux ISO 13485
    December 2018 - July 2019 (7 months)
    92300 Levallois-Perret, France
    ACAPLAST - Implementation of a system for monitoring regulations related to the activity of Medical Device assembling:
    - Diagnosis of the system and evaluation of the clients need
    - Development of an operational base in accordance with regulatory requirements and client resources
    - Formalization of the activity under identified process
    - Mapping of these processes and their interactions
    - Writing of the quality manual, procedures, flowcharts and operating procedures, highlighting the key tasks to be carried out according to the regulations. AZMED - Implementation of a quality management system:
    - Elaboration of a project monitoring grid based on normative and regulatory requirements
    - Definition, structuring and mapping of management, design and development, production and monitoring and improvement processes,...
    - Implementation of process identity cards
    - Definition of KPIs and monitoring objectives
    - Preparation and facilitation of management review and report writing
    - Preparation and awareness of certification audits
    - Preparation and animation of team training in good practices of traceability and document management.
    - System risk management process (ISO 13485)
    - Preparation and animation of training around the following themes : Vigilance, Post market surveillance, management of non-conformities Validation of software applications :
    - Analysis of risks related to the use of software applications
    - Elaboration of test protocols for validation of highly critical software
    - Training of the development team members to use the new functionalities added in the software for the ISO 13485 certification.
    - Writing of the validation report Achievement: Obtaining of the ISO 13485 - Class I CE marking
    • Check out Patricia's experience
1 recommendation
LB

Lucas Benhebbadj recommend Patricia

Education
  • Master Qualité Sécurité Environnement, Domaine Sciences, technologies, santé Mention QUALITE, HYGIENE, SECURITE INSTITUT FRANCILIEN D'IN
    Université Paris-Est Marne-la-Vallée
    2017
    Master Qualité Sécurité Environnement, Domaine Sciences, technologies, santé Mention QUALITE, HYGIENE, SECURITE INSTITUT FRANCILIEN D'IN
  • Licence, Sciences et Technologie - Option Sciences du vivant
    Université Pierre et Marie Curie (Paris VI)
    2015
    Licence, Sciences et Technologie - Option Sciences du vivant
  • Baccalauréat, Scientifique-Section Européenne
    Lycée Gaston Bachelard - Chelles - 77500
    2010
    Baccalauréat, Scientifique-Section Européenne