Quality Assurance/Regulatory Affairs Manager

COVARTIM is an engineering company that focuses on the development of medical technologies. COVARTIM helps startups, SMEs and healthcare practitioners develop and certify their medical devices, IVD medical devices and medical software.

The company is located in Brussels. Its clients are based in Belgium as well as in France, in the Netherlands, in Luxemburg, in Japan, in USA and in Brazil.

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.

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.