Freelancer profile translated to English.

Description

Biomedical Engineer graduated with a Master's degree in Biomedical Engineering & Biomaterials, specializing in regulatory affairs and quality for Class IIa medical devices (MD).

Experience in R&D on nanoparticles and therapeutic RNA.

I am looking for a new mission in an innovative and regulatory-demanding environment.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
German
Basic

Workplace preferences

Remote only

Primarily works remotely

Aesthetic Group
Engineer - Regulatory Affairs & Quality
PHARMACEUTICALS INDUSTRY
April 2023 - Today (3 years and 2 months)
MDR 2017/745 (MDD → MDR)
CE Marking (Class IIa Medical Device)
Technical File
Risk Management (ISO 14971)
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF) & Periodic Safety Update Report (PSUR)
Labeling & Instructions for Use (IFU)
Design Verification & Validation
QMS / Corrective and Preventive Actions (CAPA)
Medical Devices ISO 13485 PMS Microsoft Office CE marking

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Master 1 & 2: Biomedical Engineering and Biomaterials
Institut Galilée - Université Sorbonne Paris Nord
2023
State-registered Physiotherapist
Rabat - Morocco
2017

Other

Sara C.

Medical Writer | QARA Consultant | MDR2017 | MD

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