Менеджер по регистрации

Regulatory Affairs Expert

№47597

ИТ, Телеком и автоматизация

Москва, Россия

Регулирование

Полная занятость

Откликнуться
Our client, an international pharmaceutical company, one of the leading companies in life sciences, chemical markets and diagnostics, opens the position of a Regulatory Affairs Expert.

Обязанности

  • Ensure registration and certification of company products;
  • Identify regulatory requirements for products, determine the scope of necessary documentation, compile and review document packages for regulatory submissions, technical files etc.;
  • Maintain and update registration dossiers for medical devices in accordance with applicable regulations;
  • Manage the regulatory environment for company products, prevent barriers to trade, eliminate duplication of effort and identifies and mitigate areas of risk;
  • Provide regulatory education and dissemination to the organization;
  • Respond to inquiries from customers and authorities for product compliance;
  • Represent company to external bodies for standards and product regulations at the national/regional/global level.

Требования

  • 5+ years of experience in Russian and CIS medical device Regulatory Affairs (preferably IVD);
  • Higher education in Chemistry, Biology, Engineering or related field;
  • Understanding of international IVD regulations and Russian requirements;
  • Good knowledge of IT systems with implementation experience;
  • Fluent in English (strong written and verbal communication skills).

Комментарий

  • Competitive salary;
  • Medical insurance, travel insurance;
  • Mobile allowance.

Примечание

Поскольку каждый день мы получаем большое количество откликов, к сожалению,у нас есть возможность связаться только с кандидатами, чей профиль максимально соответствует требованиям вакансии. Получить ответ возможно в течение двух недель. Желаем успеха в поиске новой работы!