Quality Assurance/Regulatory Affairs Associate

Quality Assurance/Regulatory Affairs Associate

  • 36, Boulevard du Souverain, Watermael-Boitsfort, 1170
  • Permanent contract 
    Starting date:
    Occasional remote
    Education: Master's degree
    Experience: < 6 months

    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.

    Job description

    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.

    Preferred experience

    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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