Anne-Marie Binzangi

Qara Manager @X-Pressure

FR

I am currently working as a Quality and Regulatory Affairs Manager at XPRESSURE, with over 10 years of experience in the medical device industry. My expertise includes implementing quality management systems, leading regulatory strategies for international markets, and ensuring compliance with various regulations, notably ISO 13485, MDR 2017/745, and FDA requirements.• Implementing and managing the Quality Management System (QMS), including audits, training, and document control.• Defining international regulatory strategies and overseeing the preparation of technical files for market submissions.• Managing non-conformities, CAPA, and post-market surveillance activities.• Collaborating with authorities, subcontractors, and stakeholders to optimize product launches and lifecycle management.

Université Claude Bernard Lyon 1

First Year of Master’s Degree in Physics (EQF level 7), Physics

Université Claude Bernard Lyon 1

Bachelor’s Degree in Chemistry (EQF Level 6), Chemistry

Université Claude Bernard Lyon 1

Master’s Degree in Regulatory Affairs of Medical Devices (EQF level 7), Regulatory Affairs

Université Joseph Fourier (Grenoble I)

Master’s Degree in Medical Physics, Medical Physics