Regulatory Affairs Project Specialist (medical devices)

по договоренности

Требуемый опыт работы
От 1 до 3 лет
Занятость
Полная
График
Полный день
Образование
Не имеет значения

We are opening a competition for the position of Regulatory Affairs Project Specialist for an international project. Our client is owner of the most advanced technologies and a leader in medical products and devices market!

Kelly

Москва м. Проспект Мира
www.kellyservices.ru/
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Working conditions

  • Annual contract with the possibility of extension
  • Competitive salary, discussed in person
  • Flexible working hours and advanced social package
  • Career opportunities and international experience
  • Professional team of like-minded people

Responsibilities

  • Ensure compliance with regulatory agency regulations and interpretations
  • Prepare responses to regulatory agencies' questions and other correspondence
  • Organize and maintain reporting schedules for new device application and investigational new device applications
  • Prepare necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides
  • Provide solutions to a variety of problems of moderate scope or complexity
  • Conduct searches of existing files for requested information
  • Maintain and archive all regulatory documentation

Requirements

  • Minimum of 1,5-2 years of experience in Regulatory Affairs of medical devices (2a,2b,3 risk classes)
  • Knowledge of FDA Regulations and CE Marking
  • English - upper-intermediate

Место работы

Москва м. Проспект Мира

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