Retour aux offres d'emplois

Quality & Regulatory Affairs Assistant – F/H

Présentation société

Basée à Levallois-Perret, (92), Cardiawave SA développe une thérapie par ultrasons non invasive pour le traitement des maladies des valves cardiaques, avec un premier axe sur la sténose aortique calcifiée, la pathologie cardiaque la plus fréquente chez l’adulte. 

The role

The new team member will participate in the activities related to quality & regulatory affairs.

The responsibilities are the following and other duties may be assigned:

• Participate in the management of non-conformities, CAPA, complaint.
• Participate in QMS documentation management.
• Ensure the update of quality & regulatory affairs dashboard.
• Participate in the constitution and maintenance of technical and regulatory files (technical files, authorizations for clinical studies, registration, etc.) by gathering and structuring the necessary elements.
• Participate to regulatory and standards surveillance.

Descriptif du profil

• Apprentice in Quality and/or Regulatory affairs for Medical devices (Master degree)
• Concepts of quality management system (ISO 13845) & medical device regulation (EU MDR 2017/745).
• Knowledge of Pack office (Word, Excel).
• English (written and spoken).

Postuler

Aubine Brigitte
jobs@cardiawave.com

https://cardiawave.com/