Freelancer profile translated to English.
Back to original languageAbout Samiha
Biomedical engineer by training, specializing in the quality and regulatory affairs of medical devices. My professional background has allowed me to work on a variety of projects and become familiar with different regulations.
My skills:
- Regulation 2017/745
- Directive 93/42
- 510(K)
- ISO 13485, ISO 14971, IEC 60601-1
- ISO 62304, IEC 62366
- Anti-gift / transparency law
- Export Registration (UK, Switzerland, Israel, US, Canada)
- Quality tools (FMEA, PDCA, 5S, QQOQCP, Gantt chart ..)
Do not hesitate to contact me for any questions!
French
Native or bilingual
English
Fluent
Arabic
Native or bilingual
Can work on-site
Paris (up to 50km), Lyon (up to 10km), Lille (up to 10km)
Experience
- BALTQMS consultantPHARMACEUTICALS INDUSTRYJanuary 2026 - Today (5 months)Montmorency, France Manage quality system elements, such as monitoring system performance (internal audits, QMR, data analysis). Conduct internal audits according to the annual plan. Act as the expert for listed processes and coordinate site committees to ensure the best possible follow-up. Define relevant Key Performance Indicators (KPIs) and ensure reports are properly prepared for site managers. Lead projects to improve the quality system through change control processes. Develop and implement cross-functional process and system improvements to enhance quality, compliance, and customer service levels. Participate/support QMS project planning. Maintain and improve the current QMS map/Evaluate the impact of QMS changes on quality (organization, documentation, validation, training, premises, investments, suppliers...). Participate in global QMS communities as part of the harmonization and global monitoring project. Participate in and/or conduct internal and external audits (ensuring identified corrective actions are implemented, preparing for and participating in national authority inspections). Participate in NCA inspections and NB audits.
- ProdimedRA ConsultantPHARMACEUTICALS INDUSTRYDecember 2024 - December 2025 (11 months)Paris, FranceProject: Submission of Technical Files under MDRCompilation of technical files in accordance with Regulation (EU) 2017/745.Writing of technical file elements: PSUR, PMS report, PMCF, DGR..Participation in CE marking processes, in liaison with the notified body (GMED).Participation in the audit.Review of the drug-device combination file in collaboration with the external service provider.Review of clinical elements: CER, CEP.Devices submitted to GMED:Class III implantable combined with a medicinal substanceClass IIaOngoing medical devices (not yet submitted):Class IsClass Im
- French MushQARA ConsultantHEALTH AND WELLNESSMay 2024 - December 2024 (8 months)Paris, FranceRegistration of food supplements in the following countries:- Belgium- Italy- Spain- Portugal- Germany- Luxembourg
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Education
- Master 2 Technical and Regulatory Affairs for Medical DevicesPolytech lyon2020
- Biomedical Engineering CycleUniversité de Technologie de Compiègne2019Cycle d'ingénieur Génie biomédical (5ème année) - Echange Erasmus
Certifications
- Managing Medical Device Quality according to ISO 13485 to maintain regulatory complianceIFIS2022
- Understanding the provisions related to medical device advertisingIFIS2022