Regulatory Affairs Executive - Singapore - CorDx

    CorDx
    CorDx Singapore

    4 days ago

    Upper Management / Consulting
    Description

    Key Responsibilities

    A Regulatory Affairs Executive plays a pivotal role in product registration, serving as the subject matter expert on medical devices laws and regulations for key regions of interest. Key responsibilities include:

    1. Product Registration: Preparing registration dossiers, designing performance evaluation studies and managing their execution along with communication with Clinical Research Organizations (CROs).
    2. Liaising with regulatory agencies such as Health Science Authority, Medical Device Authority, Food and Drug Administration to track progress and resolve issues during review.
    3. Involvement in Product Testing, Clinical Verification, Data Collection & Tracking.
    4. Submission of scientific projects to regulatory bodies on behalf of the company.

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