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    Senior Regulatory Specialist - Melbourne, Australia - Brunel

    Brunel
    Brunel Melbourne, Australia

    4 days ago

    Default job background
    Full time
    Description
    Lead regulatory approval projects for medical products in key markets like EU and US Manage clinical and vigilance aspects of new and existing products Prepare and maintain medical device files for submission to global regulatory authorities Maintain regulatory license databases and systems Communicate with regulatory agencies and conformity assessment bodies Provide regulatory support to ongoing projects as needed Assist in coordinating post-market surveillance activities with FDA, TGA & EU IVDR requirements
    • Lead regulatory approval projects for medical products in key markets like EU and US
    • Manage clinical and vigilance aspects of new and existing products
    • Prepare and maintain medical device files for submission to global regulatory authorities
    • Maintain regulatory license databases and systems
    • Communicate with regulatory agencies and conformity assessment bodies
    • Provide regulatory support to ongoing projects as needed
    • Assist in coordinating post-market surveillance activities with FDA, TGA & EU IVDR requirements
    • Opportunity to work in a fast-paced environment
    • Great team culture
    • Competitive package (up to $130,000 dependent on experience)
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