Freelancer profile translated to English.

Description

Freelance QA/RA consultant specializing in medical devices. I assist startups and SMEs in structuring their quality approach, preparing for MDR/ISO 13485 audits, and drafting their regulatory documents.

Typical missions: MDR compliance assessment, SOP and QMS procedure writing, technical file review, CAPA/complaint support, CE marking guidance.

Remote intervention, fixed scope, fast delivery. Daily rate starting from €450/day.

Languages

French
Native or bilingual
Arabic
Native or bilingual
English
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

ORTHOPLUS
Quality & Compliance Manager (Class I & IIa Medical Devices)
MEDICAL
March 2023 - Today (3 years and 3 months)
Igny, France
Led QA/RA operations for an international medical device manufacturer and distributor (Europe, Asia – Vietnam, Singapore, Japan, Middle East). Ensured global regulatory compliance (MDR 2017/745, ISO 13485, local requirements: HSA Singapore, PMDA Japan). Managed the PVC to TPE material transition, with regulatory oversight and product lifecycle risk assessment. Supervised internal/external audits, managed CAPAs, complaints, and product recalls. Deployed quality indicators (KPIs), process mapping, and training plans. Contributed strategically to R&D, Production, and Management to align quality with growth objectives.
DAJAC
QA & Regulatory Affairs Manager (Class III Medical Devices)
January 2019 - January 2023 (4 years)
Houilles, France
Created and structured the Quality/Regulatory department for Class III medical devices. Fully implemented the QMS (ISO 13485:2016, MDR 2017/745) certified in under 6 months. Deployed the quality system, conducted audits, managed CAPAs, and ensured compliance for high-risk products. Served as the regulatory point of contact for suppliers, health authorities, and management.
ACCOR
Sustainable Development Project Manager (Apprenticeship)
January 2018 - January 2019 (1 year)
Paris, France
Participated in the international deployment of the Planet 21 CSR program, liaising with the Group's brands and countries. Monitored performance indicators and coordinated interdepartmental efforts.