Тип вакансииОткрытая
ОпытОт 1 года до 3 лет
Тип занятостиПолный день Полная занятость
СпециализацииМедицина, фармацевтика - Сертификация
Медицина, фармацевтика - Клинические исследования
Медицина, фармацевтика - Медицинское оборудование
Описание

Foreign pharmaceutical company is looking for Regulatory Affairs Specialist (IVD)

Responsibility:

  • Managing registration of assigned products:

  • Registration dossier preparation in accordance with the local requirements (documents creation, interaction with the manufacturer, consulting and translating agencies);

  • Local technical and clinical trial design development, coordination, report validation;

  • Timelines and budget control;

  • Managing dossier update submissions;

  • Obtaining other required documents (declarations of conformity, import permits, licenses etc.);

  • Assessing registered product changes;

  • Supporting local team on regulatory issues.

Requirements:

  • Clinical trial expertise;

  • Experience in medical device registration (preferably IVD);

  • Knowledge of local medical device regulations;

  • Higher education (biology, medicine, chemistry);

  • English – upper intermediate;

  • Result oriented, multitasking, attentive to details;

  • Excellent communication skills.


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