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Clinical Affairs Manager

Zmluva na dobu neurčitú
Watermael-Boitsfort
Plat: Neuvedené
Dátum nástupu: 18. februára 2023
Príležitostná práca na diaľku
skúsenosti: > 3 roky
Vzdelanie: Magisterský stupeň vzdelania

COVARTIM
COVARTIM

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Pozícia

Popis pracovnej ponuky

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.

Preferované skúsenosti

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.

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