Clinical Affairs Manager
This position was filled!
Who are they?
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 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.
- 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.
- Passionate about Lifesciences, technology and innovation;
- Quality and customer-service oriented;
- Strong communication and organizational skills;
- Autonomous & Quick learner;
- Flexible & open-minded.