Regulatory Affairs Intern

Job Description SummaryResponsible 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.Job Description

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.
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-

• Current enrollment in BSc or Masters program graduation years) in a medical devices field;

• 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

Additional Information

Relocation Assistance Provided: No

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