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Quality Assurance/Regulatory Affairs Associate

Zmluva na dobu neurčitú
Watermael-Boitsfort
Plat: Neuvedené
Dátum nástupu: 18. februára 2023
Príležitostná práca na diaľku
skúsenosti: < 6 mesiacov
Vzdelanie: Magisterský stupeň vzdelania

COVARTIM
COVARTIM

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Pozícia

Popis pracovnej ponuky

As part of the COVARTIM QA/RA team, the QA/RA Associate provides support for the development of innovative medical devices. (S)he provides support in Quality Assurance and Regulatory Affairs activities such as, but not limited to:

  • Quality Management System implementation at our clients site;
  • Standards watch and gap analysis;
  • Audits;
  • Compilation of documentation for notified bodies, FDA, competent authorities.

Preferované skúsenosti

Hard skills:

  • Good understanding of medical devices regulatory environment (MDD 93/42, MDR);
  • Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards;
  • English and French/Dutch.

Soft skills:

  • Passionate about life sciences, technology and innovation;
  • Quality and customer-service oriented;
  • Focused on details;
  • Strong communication and organizational skills;
  • Autonomous & quick learner;
  • Flexible & open-minded.

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