As part of the Quality Assurance/Regulatory Affairs (QA/RA) team within COVARTIM, the QA/RA Manager provides support for the development of innovative medical devices. (S)he manages 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.

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.