Description

Pharmacienne – Affaires Réglementaires & Assurance Qualité – Dispositifs Médicaux

Pharmacienne de formation, je suis spécialisée en affaires réglementaires et assurance qualité dans le secteur des dispositifs médicaux. J’accompagne les entreprises dans la conformité au règlement de différents marchés (EU, US, etc.), la rédaction de la documentation technique, les démarches auprès des organismes notifiés, et la mise en place de systèmes qualité conformes.

Disponible pour des missions ponctuelles ou un accompagnement régulier.

Industry field of expertise

Languages

English
Native or bilingual
French
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

Zoī
Qara manager
MEDICAL
December 2022 - June 2025 (2 years and 6 months)
assurance affairs manager, QMS implementation and maintenance, non conformity and CAPA management, conduct trainings, PRRC, regulatory strategy for standalone software, regulatory and standards monitoring, management review, review of promotional materials, technical folder, exchanges with a notified body, suppliers management, risk management activities, validation of software application, distribution activities, UDI, clinical evaluation strategy, management of an apprentice, ...
Animation de formation ISO 13485 MDR 2017/745 Distribution dossier technique
ResilEyes Therapeutics,
Quality assurance and regulatory affairs specialist
SOFTWARE PUBLISHING
September 2021 - December 2022 (1 year and 3 months)
QMS implementation, risk management activities, regulatory strategy for standalone software, contracts with notified body, implementation of GDPR requirements (general data protection regulation) (procedures), review of promotional materials, validation of software application, ...
ISO 13485 MDR 2017/745 IEC 62304 IEC 82304 Animation de formation
Clarteis,
Quality assurance and regulatory affairs internship
MEDICAL
March 2021 - August 2021 (5 months)
06560 Valbonne, France
Verification of design input and output data completion, , identification of applicable quality standards, risk management activities, UDI, regulatory analysis for a XVI annex device , prepation of post market clinical follow-up, clinical evaluation based on equivalence for XVI annex device (MDR), implementation of GDPR requirements (procedures), conducting training on promotional rules, ...
ISO 13485 MDR 2017/745 Mise en conformité RGPD regles de publicite ISO 14971