Regulatory Affairs Specialist

по договоренности
Москва
Опыт работы не важен

Job Responsibilities:

  • Responsible for all RA deliverable linked to the registration and certification of the medical devices in Russia, collecting the registration dossier for CIS region, maintenance of registrations in Russia and other countries of the CIS region as assigned by his/her direct manage.
  • Supporting development and execution of regulatory strategies for assigned projects for Russia. This will include the creation of submission dossier compilation of documentation and managing of timelines.
  • Monitoring submission timelines and timely responses to requests competent authorities or other partners involved in product registration. It also includes constant support for the development/ improvement of RA processes for efficient product registration in Russia.
  • Support change projects by providing RA impact assessments and support defining the necessary activities on local level.
  • Monitoring of the medical device legislation in Russia and define and maintain an overview of the regulatory requirements and changes in the areas.
  • Support in training other departments to ensure continued compliance and timely market release in Russia.
  • Support in development and execution of regulatory strategies for assigned projects for product registration and maintenance in the CIS region.
  • Accountable for regulatory compliance
  • Assessment and regulatory implementation of change requests
  • Review and approval of product related labeling
  • Monitoring legislative environment in relevant markets
  • Training internally on relevant procedures and requirements
  • Support audits by competent authorities as well as internal audits
    • Work Environment:

    • Salary - negotiable
    • Social package
      • Requirements:

      • Technical or scientific background, university degree is an advantage
      • Working knowledge of medical device legislation in Russia and corresponding guidelines
      • Additional knowledge of legislation in other countries of the CIS region is of advantage
      • Understanding of the European CE marking process
      • Good knowledge of quality system requirements such as ISO 13485
      • Additional knowledge of software development requirements (IEC 62304 and ICE 62366) as well as standards for electrical products such as IEC 60601 are an advantage.
      • SAP
      • Fluent in Russian and English (writing, reading and speaking), further languages are an advantage
      • Highly organized and able to work under deadlines
      • Strong interpersonal skills and proactive working attitude in a international matrix organisation
      • Excellent writing and communication skills
      • Minimum 3 experience in regulatory affairs within the Medical Device Industry in Russia
      • Understanding of EU medical Device regulations
        • Тип занятости:

          Временная работа, полный рабочий день, у работодателя

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