Regulatory Affairs Manager (medical devices)

по договоренности
Опыт работы не важен

Job Responsibilities:

  • Leading regulatory programs for Company in Russia & CIS to ensure compliance over product’s lifecycle;
  • Support EU trade compliance and provide registration expertise to enable business growth, compliance, customer value and competitive position;
  • Lead registration efforts to obtain and maintain product approvals in line with business targets;
  • Preparing / reviewing applications, specifications, technical files, and other necessary documents in line with local regulations.
  • Build/maintain relationships with relevant government agencies and customs.
  • Monitoring the local legislations and registration documentation. Implement necessary changes if needed.
  • Local IFU/labeling support
  • Deliver regulatory support to internal and external interfaces in the country.
    • Work Environment:

    • Official employment;
    • Meal and Telephone compensations;
    • Voluntary health insurance;
    • Professional development opportunities;
      • Requirements:

      • University degree in pharmacology, chemistry, toxicology, engineering or related life science degree with over ten years of professional experience;
      • Highly valued proven professional experience on Trade Compliance.
      • Familiarity with regulatory requirements and standards governing trade compliance, import, distribution and sales in Russia & CIS;
      • Track record of exposure to relevant regulatory agencies and customs;
      • Strong leadership and interpersonal skills;
      • Business acumen and good communication skills;
      • Structured working habit and practical thinking;
      • Passion and proactive attitude;
      • Required Language skills: English (upper-intermediate).
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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