Regulatory affairs specialist (medical devices)

по договоренности
Москва
Опыт работы не важен

Company:

Large international multibusiness company.

Job Responsibilities:

  • Perform registration and certification/declaration processes for medical devices business
  • Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
  • Registration dossier preparation
  • Ensure timely registration of all new products and obtaining of relevant licenses
  • Review product registrations for accuracy and completeness of documentation
  • Ccooperation with outsoursing companies
  • Responsible for accurate documentation of new products for submissions to authorities
  • Local RA and QA Audits attendance
  • Maintain and update RD Database: enter new documents to DB and notification of all concerned parties (upon appropriate mailing list)
  • Certificates tracking and update in time according business needs
  • Dossiers archiving
  • Approve: SAP codes, IFU, Advertising materials
  • Provide trainings: RA, SOP Advertising
  • Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process
    • Work Environment:

    • Salary level is discussed on the interview according to candidate's experience.
    • Direct hiring contract.
    • Medical insurance, corporate mobile phone, fitness compensation, annual bonus.
      • Requirements:

      • Higher education (Biomedical engineering education / background is a strong advantage)
      • 1 + of experience in Regulatory Affairs in Medical Devices preferably
      • Knowledge of English language, sufficient for business communication purposes
      • Result-oriented, initiative, proactive
      • Team player
      • Good communication skills (collaborative approach), open-minded
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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