Regulatory Affairs Project Specialist

по договоренности
Москва
Опыт от 1 до 3 лет

Job 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
    • Work Environment:

    • 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
      • Requirements:

      • Minimum of 1,5-2 years of experience in Regulatory Affairs
      • Knowledge of FDA Regulations and CE Marking
      • English - upper-intermediate
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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