Stéphanie H.

Member of the Company Leadership team as QARA Director Successful QMS implementation from scratch (from definition to implementation followed by training) Definition of a regulatory strategy to put an active medical device on the EU market (CE marking) and on the US market (510(k) clearance) Lead successful CE marking project from notified body selection and management to compliant technical documentation and QMS issuance Data Privacy Officer for health data processed by the medical device Budget management

Implementation of a DI culture (robust processes, clear procedures, DI tools, trainings) Support for the implementation of the new DI processes on site Supervision of the DI remediation action plan and of DG processes

Risk based supplier management process definition Supplier audit Quality agreements negotiations New material introduction