Freelancer profile translated to English.
Back to original languageAbout Oumaima
Specialist in regulatory affairs and quality for MD and IVD with 4 years of experience in CE marking, MDR/IVDR, 510(k), and ISO 13485. Involved in technical files, regulatory compliance, and follow-up with authorities and notified bodies.
French
Native or bilingual
English
Fluent
Spanish
Conversational
Arabic
Native or bilingual
Can work on-site
Marseille (up to 50km), Lyon (up to 50km), Paris (up to 50km)
Experience
- WinbackRAQA ConsultantMEDICALMay 2025 - July 2025 (2 months)Villeneuve-Loubet, France- Management of change control and drafting of Letters to File justifying the absence of significant impact from product modifications- Creation, update, and validation of regulatory documentation: labeling, packaging, and user manuals compliant with Regulation (EU) 2017/745 (MDR)- Multi-market regulatory intelligence: FDA (USA), CE (EU), ANVISA (Brazil)- Drafting of the Swiss Authorized Representative (CH-REP) contract in accordance with the Ordinance on Medical Devices for access to the Swiss market- Participation in V&V activities (definition of protocols, execution of tests, and test reports)
- AVICENNA La CiotatRegulatory Project Manager in Software as a Medical Device (SaMD) Development Integrating AIMEDICALNovember 2022 - December 2024 (2 years and 1 month)La Ciotat, France- Drafting of design documentation for Class IIb software medical devices (SaMD)- Planning and execution of verification & validation (V&V) activities- Creation and updating of tracking tools and project schedules- Coordination of multidisciplinary teams for development and maintenance projects- Development of 3 510(k) submissions in eSTAR format submitted to the FDA- Updating technical files during the transition from MDD to MDR- Management of documentation updates: distribution of responsibilities and progress tracking during the MDD to MDR transition and device maintenance activities- Management and drafting of risk management files (plan, analyses, matrices, and report)- Development and updating of DHF and DMR following product development and maintenance activities
- Horiba MedicalIVD Regulatory Affairs ConsultantSeptember 2021 - October 2022 (1 year and 1 month)- Updating of Class A, B, and C IVD technical files according to IVDR, UKCA, and RoHS regulations- Drafting of GSPR (General Safety and Performance Requirements) matrices with regulatory justification and documentary traceability- Drafting of declarations of conformity- Review and verification of documents: Risk management file, performance documents, labeling, user manual, clinical documents- Resubmission of technical files following Notified Body Non-Conformities- Facilitation and participation in exchanges with the notified body
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Education
- Master of International StudiesInstitut Supérieur des Ingénieurs de Franche Comté (ISIFC)2020Master International en Ingénierie biomédical (ISIFC)
- Professional License in Biomedical Engineering (UIASS)Université Internationale Abulcasis des Sciences de la Santé (UIASS)2018License professionnelle en génie biomédical (UIASS)
Skill set (13)
Categories
- Other