Специалист по регистрации (lдекретная ставка)

Regulatory Specialist (Maternity leave position)

№48937


Медицинское оборудование

Москва, Россия

Регулирование

Временная занятость

Откликнуться
Global leader in blood component and cellular technologies is looking for Regulatory affairs coordinator. Job Summary Working under supervision, assists the regulatory team in routine submissions and maintenance of existing registrations for medical devices in the area of blood component technologies and cell processing

Обязанности

  • Using a basic knowledge and understanding of regulatory requirements in Russia. 
  • Plans and arranges own activities, with work being reviewed upon completion. 
  • Interacts with regulatory consultants and authorized respresentative in RussiaInteracts with and/or directs others in interacting with regulatory and certification authorities. 
  • Identifies and defines administrative andlegal) requirements for regulatory submissions. 
  • Leads obtaining these documents for their timely submission to regulatory authorities. 
  • Proactively advises business management of regulatory and certification issues in Russia. 
  • Uses a positive, collaborative approach to creating solutions to regulatory/compliance challenges. 
  • Identifies areas where the business can effect improvements and establishes 
  • Working Instructions.Stays current on changing regulatory requirements in Russia and the upcoming Eurasion Economic Union legislation.
  • Acts as liaison with regulatory teams, commercial teams and distributors to facilitate product approvals and compliance issues.

Требования

  • Experience in Regulatory Affairs position with russian law is a must 
  • CIS countries knowledge is advantage 
  • Euresian economic union: be aware of the new legislation for the area of Russia (and around)

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!