Freelancer profile translated to English.
Back to original languageAbout Jean Philippe
With extensive experience in quality and regulatory engineering in the fields of medical devices, agri-food, biotechnology, and chemistry, as well as in medical and forensic biology laboratories, I can provide you with advice and training for your quality system projects (ISO 9001, 13485, or 15189), CE marking of medical devices, technical file preparation, post-market surveillance file preparation, and also to act as the person responsible for regulatory compliance (PCVRR).
I am a certified ICA AFNOR auditor for ISO 13485 audits and quality management system audits for CE marking.
French
Native or bilingual
Can work on-site
Paris (up to 50km)
Experience
- MEDISSIMOQuality and Regulatory Affairs Manager (Part-time)HEALTH AND WELLNESSFebruary 2023 - Today (3 years and 4 months)Poissy, FranceQuality and regulatory affairs, CE regulatory technical file for digital medical devices, PCVRR
- INSTITUT CURIEInternal Auditor to the PresidencyJanuary 2020 - January 2022 (2 years)Université de Lille − Siège, Lille, Francein partnership with INSERM, CNRS, University of Paris – 2700 employees – Headquarters – Paris – www.curie.frInternal Auditor to the Presidency• Planning and conducting high-stakes internal audits upon request from the Executive Board and/or requested by Entity Directors: clinical trial processes, R&D and technology transfer processes, care and medical biology processes, research processes, biobank activities, management processes• Conducting and updating the institution's major risk mapping
- INSTITUT NATIONAL DE LA TRANSFUSION SANGUINEQuality and Regulatory Affairs ManagerJanuary 2009 - January 2020 (11 years)Paris, FranceMinistry of Health/INSERM/Paris VI Faculty of Medicine – 180 employees – General Directorate – Paris - www.ints.frQuality and Regulatory Affairs Manager (Head of Department: 5 staff members)• Design and deployment of the institute's quality policy and risk management with respect to clients (healthcare professionals, client laboratories, healthcare facilities, notified bodies, biomedical firms)• Implementation and management of quality initiatives for medical biology and biotechnology activities (production of IVDRs) according to normative and regulatory standards ISO 17025, ISO 15189, GBEA, and ISO 13485/EC Regulation 2017/746 (In Vitro Diagnostic Medical Devices), GLP; CE technical files, supplier quality assurance, control plan, method validation, vigilance, internal quality and risk management audit plan• Liaison with certification and accreditation bodies (GMED, COFRAC, AFNOR) and interprofessional organizations in the field of quality and health risks (LABAC, learned societies, EFS…)
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Education
- Veterinary Doctor(Nantes School)1987Docteur Vétérinaire
- Diploma of Higher Specialized Studies in Business Administration(Institute of Business Administration – Faculty of Economics of Aix en Provence)1994Diplôme d'Etude Supérieure Spécialisée d'Administration des Entreprises
Skill set (12)
Categories
- Other