Regulatory Affairs Specialist (in vitro)

по договоренности
Москва
Опыт работы не важен

Job Responsibilities:

  • Responsibility for insuring earliest possible registration of all new or in-line products, claims, formulations and/or strengths, along with price registration/re-registration, shelf-life changes according to adopted registration strategies (and company's high ethical standards policy).
  • Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
  • Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
  • Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normative documents related to registration of medical devices.
  • Cultivating best possible relations with local regulatory bodies and opinion leaders and enhancing the Company's image in the medical community in general.
  • Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
  • Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.
    • Work Environment:

    • Medical insurance for the employee and his children (100% coverage);
    • Medical insurance for a spouse (50% coverage);
    • Life insurance (accidents)
    • Employee assistance programs
      • Requirements:

      • Higher education
      • At least 1 years of experience in Regulatory Affairs (medical devices, pharma)
      • English – written, spoken
      • Excelent knowledge of MS Office (Word, Excel)
      • Personality: team player, well organized, attentive to details, enthusiastic, quick learner
      • Ability to work with big amount of information
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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