Freelancer profile translated to English.

Description

After several years in Clinical Trials & Medical Affairs, I decided to specialize in Medical Devices to advise and support companies in implementing a Quality Management System according to ISO 13485 and compliance with MDR Regulation 2017/745. I also work on EUDAMED registration, clinical evaluation of medical devices, and the role of PRRC.

Furthermore, audits have always been an integral part of my daily work; I have been both audited and auditor throughout my career, which is why I leverage my long expertise in this field.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Arabic
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

KYLYS AESTHETICS
Quality & Regulatory Expert
MEDICAL
November 2025 - Today (9 months)
Genève, Switzerland
Implementation and support for the implementation of a Quality Management System according to ISO 13485
MDR 745 Certification
ISO 13485 MDR 2017/745 ISO 14971 Quality Management
NEOMEDIS
Quality & Regulatory Expert
June 2024 - Today (2 years and 2 months)
Review of the quality management system, regulatory support and advice.
Regulatory & normative watch.
BIO-STERIL contract manufacturing
Audit supplier 13485
CONSULTING AND AUDITS
June 2023 - June 2023
Lyon, France
Review/audit of the QMS
Manufacturing process audit,
NC/CAPA Management
Supplier evaluation
Supplier Audit