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.
Role 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 Russia
Prepare 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 internal
customers in accordance with procedure
2. Handling requests from internal and external customers about registration certificates
3. Ensure payment of regulatory invoices in time
4. Carry out the process of documents storage
5. Administrative support
Qualifications-
Characteristics-
1. One or more years relevant experience in the healthcare industry
2. Bachelor's degree
3. One or more years relevant experience in the healthcare industry
Relocation Assistance Provided: No
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