Freelancer profile translated to English.
Back to original languageAbout Rémy
Regulatory Affairs Specialist for Medical Devices and In Vitro Diagnostic Devices. I offer my support in all regulatory steps for the registration or maintenance of your registrations in Europe (IVDR, MDR, MDD, and IVDD), USA (510k), as well as throughout the Asia-Pacific region (China, Japan, Singapore, Australia, etc.).
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-aiRAQA ManagerMEDICALDecember 2022 - Today (3 years and 6 months)Paris, France- Implementation of ISO 13485 / IEC62304- Preparation of technical documentation
- 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 Computer ScienceIUT Lyon 12015Programmation Informatique Base de donnée Qualité logiciel
- Biomedical EngineerPolytech' Lyon 12018Technical knowledge (Physics, electronics) Human anatomy and physiology. Quality management (ISO 13485, materiovigilance) Software quality (IEC 62304, “V” cycle)
Skill set
Categories
- Other