Pour postuler à cette offre, l'envoi de votre CV est obligatoire.
Le télétravail occasionnel est autorisé pour ce poste.
Le contrat pour ce poste est de type CDI.
La lettre de motivation est obligatoire pour postuler à cette offre.
Le contrat pour cette offre de job démarre le 31 août 2022
Le poste
Descriptif du poste
As part of the Quality Assurance/Regulatory Affairs (QA/RA) team, the QA/RA Manager will provide support for the development of innovative medical devices. (S)he will manage QA/RA activities such as, but not limited to:
Quality Management System implementation;
Standards watch and gap analysis;
Audits (internal/external);
Review and preparation of documentation packages for notified bodies, FDA, competent authorities.
Profil recherché
Hard skills:
Good understanding of Medical Devices and IVD regulatory environment (directives, regulations);
Good knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards;
Fluent in English and French/Dutch.
Soft skills:
Quality and customer-service oriented;
Focused on details;
Team-player with strong communication skills;
Ability to work cross-projects and excellent organizational skills;
Autonomous and eager to learn;
Strong interest in Lifesciences, Technology and Innovation.