Freelancer profile translated to English.
Back to original languageAbout Michele
Regulatory requirements in the medical device sector are continuously evolving, which can sometimes pose complex challenges for companies in their implementation. With over 8 years of expertise in the medical device field, I can offer my services to help you ensure the compliance of your Quality Management System (QMS), your technical documentation, and the execution of your quality and regulatory audits.
French
Native or bilingual
English
Fluent
Remote only
Primarily works remotely
Experience
- DuponRegulatory Affairs ManagerMEDICALMay 2021 - Today (5 years)Paris, FranceDefinition and implementation of the regulatory strategy, obtaining and maintaining ISO 13485 certifications and CE marking, preparation and monitoring of technical files (Risk Management, preclinical studies, clinical evaluation, post-market surveillance PMS/PSUR/PMCF), registration of medical devices.
- Cooper Consumer HealthRegulatory Affairs SpecialistPHARMACEUTICALS INDUSTRYFebruary 2021 - May 2021 (4 months)Paris, FranceRisk management of medical devices according to ISO 14971.Definition of the clinical strategy according to the class of medical devices in accordance with the MDR,Clinical evaluation and post-market surveillance PMS/PSUR/PMCFRegistration of medical devices.
- ISOMEDRegulatory Affairs and Quality ManagerPHARMACEUTICALS INDUSTRYOctober 2019 - February 2021 (1 year and 4 months)Paris, FranceDefinition and implementation of the regulatory strategy,Management of the transition from MDD to MDR for class III, II, and I implantable devicesObtaining and maintaining ISO 13485 certifications and CE marking,Implementation of a Quality Management System (QMS),Preparation and monitoring of technical files (Design File, Risk Management, preclinical studies, clinical evaluation, post-market surveillance PMS/PSUR/PMCF),Registration of medical devices,Conducting quality (QMS) and regulatory (Technical Files) audits.
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Education
- Master 2 in Marketing/Communication of Health ProductsParis VI2017M2 Marketing/Communication des produits de santé
- Master 2 in Regulation/Quality of Health ProductsV|20162016M2 Reglementation/Qualité des produits de santé
Skill set (8)
Categories
- Other