RA Coordinator (1yr fixed-term)

Job Description Summary

The Regulatory Affairs Coordinator is responsible for handling EU MDR project and NoCs.

Job Description

Main Responsibilities

• Temporary hiring for EU MDR/IVDR and NoCs
• Communicates and aligns/supports with RA team and business, international RA folks, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay.
• Reviews the documents and prepares/submits for technical file/product approvals to the local authority.
• Monitors change notifications to analyze the impacts of the product license and completes proper actions for the changes
• Maintains and archives all the related documents for registration; maintain and regularly update the product master files.
• Prepares and maintains the product Korean labels/IFUs to meet local regulations and company procedures
• Translates the documents to submit the local authority
• Performs other activities assigned and/or instructed by direct manager

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• Minimum of a Bachelor Degree in Biomedical Engineering, Biochemistry, Chemistry, Pharmacy, or related science
• Minimum 1 year prior experience working in Regulatory Affairs preferred
• Good English communication skills(writing and speaking)