Pri reagovaní na túto ponuku je potrebné pripojiť životopis.
Pri tejto pozícii je možná občasná práca na diaľku.
Zmluva pre túto pozíciu je : Plný úväzok.
Pripojenie motivačného listu pri reagovaní na túto ponuku je povinné.
Predpokladaný termín nástupu na túto pozíciu je 31. augusta 2022
Pozícia
Popis pracovnej ponuky
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.
Preferované skúsenosti
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.