Вакансии

  • Москва
  • Полный рабочий день

Regulatory Affairs Expert

17 января 2018, 16:20

RESPONSIBILITIES:



  • Ensure registration and certification of In vitro diagnostics and Metrology products in Russia.
  • Develop and implement programs / processes for the registration of these products ensuring regulatory requirements are met.
  • Provide Guidance and Clarification to the internal team for regulatory requirements. Ensure regulatory project deadlines and performance standards are established and met.
  • Represent company to external bodies for standards and product regulations at the national/regional/global level.
  • Assess requirements and identify strategies for earliest possible approvals of clinical trials applications.

REQUIREMENTS:



  • Degree in in Chemistry, Biology, Engineering or related field.
  • 5+ years of experience in Russian and CIS medical device Regulatory Affairs (Preferably IVD).  Additional experience in Metrology registration preferred.
  • Understanding of international IVD regulations and Russian requirements.
  • Strong written and verbal communication skills in English.

CONDITIONS:



  • Work experience in an international company.
  • Competitive salary (is discussed).
  • Life insurance, voluntary medical insurance and so on.

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