About Rémy
Spécialiste Affaires Réglementaires DM et DMDIV. Je me propose de vous accompagner dans toutes les démarches réglementaires pour l'enregistrement ou le maintien de vos enregistrement en Europe (IVDR, MDR, MDD et IVDD), USA (510k) ainsi que toute la zone Asie Pacifique (Chine, Japon, Singapour, Australie,...).
French
Native or bilingual
English
Fluent
Can work on-site
Lyon (up to 50km), Grenoble (up to 10km), Valence (up to 10km), Saint-Étienne (up to 10km), Montpellier (up to 10km)
Experience
- Spimed-aiResponsable RAQAMEDICALDecember 2022 - Today (3 years and 6 months)Paris, France- Mise en place ISO 13485 / IEC62304- Préparation dossier technique
- BaxterRegulatory affairs specialistPHARMACEUTICALS INDUSTRYMay 2022 - Today (4 years and 1 month)Lyon, France• Preparation of regulatory files for registration, renewal, and change.• Assessment of regulatory impact.• Work for US FDA (PMA, 510(k)) and CE mark (2017/745 and 2017/746)
- VeracyteQuality managerPHARMACEUTICALS INDUSTRYApril 2022 - June 2022 (3 months)Marseille, FranceQuality representative for an IVD Software development.Work with and on IEC62304 and ISO13485Write of new procedure linked to IEC62304 and ISO13485
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Education
- DUT InformatiqueIUT Lyon 12015Programmation Informatique Base de donnée Qualité logiciel
- Ingénieur biomédicalPolytech' Lyon 12018Technical knowledge (Physics, electronics) Human anatomy and physiology. Quality management (ISO 13485, materiovigilance) Software quality (IEC 62304, “V” cycle)
Skill set
Categories
- Other