Regulatory affairs intern, Medical devices

50 000 руб
Размещено 19 апреля


На работу требуется regulatory affairs в г. Москва.Job Description Summary Responsible for assisting the GE Healthcare regulatory team in gaining approvals and maintaining the regulatory compliance of the business. The role will primarily be involved in, but not limited to, the collection, organization and submission of information related to medical devices reports, corrections and removals, and other mandatory requirements for medical devices, as well as providing general administrative support to the regulatory team to facilitate regulatory services to the business. Responsibilities 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 RussiaPrepare and submit the dossier for receiving the Notification for all products;Ensure translation and notarization of Regulatory documents through translation agency. Registration of Medical Devices for some CIS countries Key Regulatory processes support and coordination:1. Weekly update of local Regulatory databases and trackers, communication to internalcustomers in accordance with procedure2. Handling requests from internal and external customers about registration certificates 3. Ensure payment of regulatory invoices in time4. Carry out the process of documents storage5. Administrative support Qualifications: Current enrollment in Bachelors or Masters program (2025 - 2027 graduation years) in a medical devices field Able to work 25-40 hours per week 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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