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    APAC Regulatory Specialist II - Alameda, United States - INTELLECTT INC

    Intellectt Inc background
    Description

    Role:
    Regulatory Specialist IILocation: Alameda, CA Duration: 12 MonthsJob Descriptionfor regulatory activities, including product registrations, impact assessment, etc.

    Understand country-specific requirements and deliver those to internal stakeholders, includingmanagement, engineering, labeling, etc., for product registration and change planningweekly with affiliate RAs in different time zones to catch up on ongoing projectsdiscuss the issues to execute the given tasks proactively in a timely manner.

    Report the status to a manager training records up to date to do the tasks.

    OtheKnowledge of International Standards, such as ISO13485, IEC60601Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, Agile, SharePoint, MS Office, and other software to increase work manage time and projects.

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