As part of the Development team within COVARTIM, the Clinical Affairs Manager provides support for the development of innovative medical devices, . (S)he will manage Clinical Affairs activities such as, but not limited to:

• Preparation of CEP and CER;
• Management of clinical investigation;
• Set up and follow up of PMS, PMCF, PSUR;
• Review and preparation of documentation packages for notified bodies, FDA, competent authorities.

Hard skills:

• Good understanding of medical devices and IVD regulatory environment;
• Good knowledge of medical devices clinical investigation clearance process (EU and US);
• Good knowledge of medical devices risk management, CIP, CIR, CEP, CER, PMS, PMCF, PSUR;
• English and French/Dutch.

Soft skills:

• Passionate about Lifesciences, technology and innovation;
• Quality and customer-service oriented;
• Strong communication and organizational skills;
• Autonomous & Quick learner;
• Flexible & open-minded.