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    Regulatory Specialist II - Alameda, United States - The Fountain Group

    The Fountain Group
    The Fountain Group Alameda, United States

    3 weeks ago

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    Description
    The Fountain Group is a national staffing firm and we are currently seeking a Regulatory Specialist for a prominent clientof ours. This position is located in Alameda, CA (onsite)

    Details:
    • THIS POSITION IS 100% ONSITE
    • Pay for this position is 56.00 to 60.00 hourly depending on experience
    • This position is a one year contract with the possibility of extension or conversion to permanent.
    Required:
    • 5+ years of regulatory affairs experience
    • Medical Device regulatory affairs experience
    Job Description:
    • Responsible for regulatory activities, including product registrations, impact assessment, etc.
    • Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
    • Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
    • Plan and execute the given tasks proactively in a timely manner.
    • Report the status to a manager weekly.
    • Keep the training records up to date to do the tasks.
    Other Preferred (not required) Experience:
    • Bilingual (Japanese or Chinese)
    • Knowledge of International Standards, such as ISO13485, IEC60601.
    • Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
    • Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
    • Ability to manage time and projects.
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