Специалист по регистрации in vitro

Responsibilities:

• Organization of product registration process in Russia (full cycle):
• Collecting the documents from the manufacturer
• Preparation of normative and technical files
• Obtaining of importation permits for registration purpose
• Organization and document support for performing inspection (2b,3 classes)
• Collaboration with testing laboratories
• Cooperation with translating agencies and notary office
• Compilation and submission of registration dossier to the competent national regulatory authority
• Regulatory and Technical document support for product registration in CIS
• Obtaining of enabling documentation for circulation of medical devices in Russian&CIS market (metrology certificates,TMs, permissions and )
• Maintenance of databases with valid registration licenses and registration dossier archive in Russian&CIS
• Cooperation with International Regulatory Affairs
• Assistance in planning, timing and cost estimation of product registration activities in Russia&CIS
• Tracking standards, regulations and all applicable requirements related to circulation of medical devices in Russian&CIS
• Assistance in efforts to ensure the products are properly registered and in compliance with applicable local and international regulations
• Aassistance in the execution of post market surveillance activities: complaint evaluation, medical device reporting, vigilance reporting, product correction, removals, and recalls.
• Registration of products in TROIS and coloboration with custom authorities when counterfeit products are detected
• Design and implementation of labels in accordance with the general principles laid down in Russia&CIS Regulations
• Coordination of medical products localization process in Russia (knowledge of regulatory requirements, standards and the process itself)

Requirements:

• Minimum 5 years in Regulatory Affairs or combination experience in regulatory affairs and quality assurance
• Minimum 2 years in Regulatory Affairs for in vitro diagnostics
• Experience working in a medical device or pharmaceutical environment
• Awareness of the requirements of relevant local and international regulations
• Strong computer skills required: MS Office, Excel, Power Point
• Language: English (intermediate). Good skills in oral and writing communication

Employment conditions:

• Official employment
• Voluntary health insurance (VHI)
• Bonuses
• Hybrid work format
• Mobile phone allowance