Freelancer profile translated to English.
Back to original languageAbout Ouma
I support companies in registering their medical devices, managing product lifecycles, conducting product risk management files, gap analysis, and regulatory monitoring.
French
Native or bilingual
English
Native or bilingual
Spanish
Basic
Can work on-site
Provins (up to 10km)
Experience
- ETKRegulatory Affairs OfficerRAW MATERIALS INDUSTRYAugust 2022 - September 2023 (1 year and 1 month)Écully, FranceTechnical file writingRisk management file writingLabel specification preparation
- VYGONRegulatory AffairsRAW MATERIALS INDUSTRYFebruary 2022 - May 2022 (3 months)Technical file writingSummaries of files (Usability, Risk Management, CER, CEP, PMCF)Writing Notes To File (change management)Gap Analysis (MDR 2017/745)
- VeracyteQA/RA SpecialistBIOTECHAugust 2021 - January 2022 (5 months)Technical file writing according to MDR 2017/746 for CE markingWriting test verification summariesSummary of PEP & PER
Recommendations
Be the first to recommend Ouma
Help this freelancer shine by sharing your experience working together.
These freelancer profiles also match your criteria
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Education
- Master in Technical and Regulatory Affairs for Medical DevicesPolytech Lyon2020
- Master in Design and Production of Health ProductsUniversity of Montpellier2016
Skill set
Categories
- Other