Freelancer profile translated to English.
Back to original languageAbout Yahia
QARA Engineer specializing in Software as a Medical Device (SaMD), with a Master's degree in Biomaterials & Medical Devices from the University of Bordeaux.
Operational experience gained within an innovative MedTech startup, in an ISO 13485 certified environment compliant with MDR 2017/745, with multi-market commercialization (Europe, United States, Australia).
What I bring concretely:
Management and optimization of complete technical files for medical device software (IEC 62304 / IEC 82304), from project launch to deployment.
Preparation and participation in Notified Body audits (TÜV Rheinland), managing non-conformities and CAPAs.
Drafting of design reviews (Specification Review, Mockups Review, Validation Report) in compliance with the V-model.
Gap analysis of new standards (BS EN ISO 34971, AI and risk management).
Active contribution to Regulatory Affairs processes: regulatory monitoring, FDA 21 CFR compliance, MDR.
Risk analysis (ISO 14971).
Trilingual French / English / Arabic, capable of working on technical files entirely in English.
Available for freelance QARA Medical Device missions: Drafting and management of technical files, MDR/FDA compliance, gap analysis, preparation for Notified Body audits.
French
Native or bilingual
English
Fluent
Arabic
Native or bilingual
Can work on-site
Toulouse (up to 50km)
Experience
- Logiciel inHEARTQuality & Regulatory Affairs EngineerMEDICALJanuary 2024 - July 2024 (6 months)Bordeaux, France▸ Drafting and updating technical documentation for medical device software (IEC 62304 / IEC 82304, V-model, Design Reviews, Risk Management and Analysis).▸ Participation in Notified Body surveillance and re-certification audits: preparation, CAPA, follow-up.▸ Analysis of the BS EN ISO 34971 standard in collaboration with R&D.▸ Maintenance of the QMS in accordance with ISO 13485, MDR 2017/745, and FDA requirements.
- NorautoFast Service ReferentDecember 2024 - Today (1 year and 6 months)Toulouse, France▸ Operational coordination and team supervision in a strict procedural environment.▸ Guarantee of service quality, safety procedures, and process consistency.
- Laboratoire ACHIFAObservation InternshipMEDICALApril 2022 - April 2022Batna City, BT, Algeria▸ Observation of the functioning of in vitro diagnostic medical devices and bone scintigraphy imaging (Nuclear Medicine)
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Education
- Master's in Health Engineering — Biomaterials & Medical DevicesUniversity of Bordeaux2024Réglementation DM, mécanique des fluides, physiologies, gestion de projet, biomatériaux, imagerie médicale, CFAO (CREO / SolidWorks).
- Bachelor of Science, Technology & Health, biotechnologies for healthUniversité Grenoble Alpes2021Biologie moléculaire, biochimie, génétique, microbiologie, communication scientifique FR/EN.
Certifications
- RISE! with .emt "Develop your digital health innovationsMD1012024
Skill set
Categories
- Other