Clinical Affairs Manager - Watermaal-Bosvoorde, België - Covartim
Beschrijving
Functieomschrijving:
The Clinical Affairs Manager shall provide support for the development of innovative medical devices, as part of the development team within COVARTIM.
- 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
Location
Boulevard du Souverain 36, 1170 Watermael-Boitsfort (Brussels)
Function type
Full time open-ended
Background:
Min. 3 years of relevant experience in Medical Devices QA/RA functions.
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 customerservice oriented
- Strong communication and organizational skills
- Autonomous & Quick learner
- Flexible & openminded
- The opportunity to contribute to the development of products that will improve or save people's life
- A valorizing job within an ambitious and growing company in a booming industry
- A great team of enthusiastic people led by passionate experts in MedTech
- A nice working environment in our new office located in Brussels, close to the forest of Soignes, a park, nice shops and restaurants, public transport connections and the E41
- And of course, a good salary package and extra benefits
Managing Director
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