Regulatory Affairs Intern

Job Description

• Obtain Declaration of conformities a) request for approval of Declaration of conformity renewal from Modality; b) submit the request about Declaration of conformity in to Certification Center;
• Prepare notarization copies of registration documents (DOC and RC);
• Prepare and submit the dossier for receiving Radio Frequency Approval/Exemption letters from GKRCH;
• Prepare and submit the dossier for receiving the license for shipment MRI to Russia;
• Prepare and submit the dossier for receiving the Notification for all products;
• Prepare and submit the dossier for receiving the Metrology Certificate;
• Ensure translation and notarization of Regulatory documents through translation agency;
• Registration of Medical Devices for CIS countries Key Regulatory processes support and coordination:
• Weekly update of local Regulatory databases and trackers, communication to internal customers in accordance with procedure;
• Handling requests from internal and external customers about registration certificates and Declaration of conformities copies;
• Ensure payment of regulatory invoices in time;
• Carry out the process of documents storage;
• Administrative support.

Qualifications

• 4-6 year university student;
• Fluent English (upper-intermediate and higher) and Russian;
• Open-minded, fast learner, eager for professional development;
• Structural, good executor, experienced PC user (Excel, Word, Power Point, Adobe);
• Active life position;
• Excellent communication skills;
• Skills of planning and self-organization;
• Eligible to work in Russia;
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