Description

✨ Experte en Assurance Qualité & Affaires Réglementaires (Dispositif Médical/Cosmétique) 🌐

🔍 20 ans d'expérience guidant startups et grandes entreprises dans l'univers exigeant des dispositifs médicaux de Classe IIa/IIb et III 💉 Expertise avérée en Assurance Qualité (ISO 13485) et Affaires Réglementaires (MDR 2017/765). J'ai piloté avec succès des projets de mise en place de Systèmes de Management de la Qualité et assuré la conformité CE ainsi que l'enregistrement à l'export 🎯

💥 Vous avez un projet de développement qualité ou règlementaire ? Nous pouvons en discuter ensemble !

Industry field of expertise

Languages

English
Native or bilingual
Spanish
Conversational

Workplace preferences

Can work on-site

Aix-les-Bains (up to 50km)

Freelance [FR]
QA/ RA Consultant
MEDICAL
January 2022 - Today (4 years and 5 months)
QA/ RA support to startup
QA/ RA interim
Regulatory expertise
Support to QMS deployment
One-shot projects: regulatory evaluation, technical file review, regulatory watch, technical writting, internal audits.
Softmesology (FR)
QA/ RA Director
MEDICAL
January 2020 - January 2021 (1 year)
Company: Startup - Medical devices (active, software) / Cosmetics

QMS deployment from scratch (ISO 13485, MDR)
QA/RA expert for design projects (risk management, pre-cinical/ clinical strategy).
Single Point Of Contact for authorities and notified bodies.

Management: 1 engineer.
Kylane Laboratoires (CH)
Compliance Director
MEDICAL
January 2017 - January 2019 (2 years)
Company: Startup - Medical devices class III (HA Fillers)

QMS deployment from scratch (ISO 13485, MDR)
Technical file management.
Batch release.
QA approver for validations and QAA.
QA/RA expert for design projects (risk management, pre-cinical/ clinical strategy).
Regulatory strategy (Europe/ export).
Advertising control.
PMS.
Audits: Internal, suppliers, CDMO.
Single Point Of Contact for authorities and notified bodies.

Achievements: ISO granted in 2017, CE granted in 2019