Clinical Affairs Manager
Functieomschrijving
The Clinical Affairs Manager shall provide support for the development of innovative medical devices, as part of the development team within COVARTIM. (S)he will manage Clinical Affairs activities such as, but not limited to:
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Preparation of CEP and CER
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Management of clinical investigation
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Set up and follow up of PMS, PMCF, PSUR
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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 customer-service oriented
- Strong communication and organizational skills
- Autonomous & Quick learner
- Flexible & open-minded
Ons aanbod
- 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 E411
- And of course, a good salary package and extra benefits!
Solliciteer
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