As part of the COVARTIM QA/RA team, the QA/RA Associate provides support for the development of innovative medical devices. (S)he provides support in Quality Assurance and Regulatory Affairs activities such as, but not limited to:

• Quality Management System implementation at our clients site;
• Standards watch and gap analysis;
• Audits;
• Compilation of documentation for notified bodies, FDA, competent authorities.

Hard skills:

• Good understanding of medical devices regulatory environment (MDD 93/42, MDR);
• Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards;
• English and French/Dutch.

Soft skills:

• Passionate about life sciences, technology and innovation;
• Quality and customer-service oriented;
• Focused on details;
• Strong communication and organizational skills;
• Autonomous & quick learner;
• Flexible & open-minded.