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      • Regulatory Affairs Specialist

        Prepare and submit regulatory applications to international agencies.

         

        Description

        • Manage preparation, submission, and maintenance of regulatory applications to multiple agencies (FDA, Health Canada, NMPA, TGA, HSA, EMA)
        • Work closely with MI's Clinical Safety Officer, Chief Scientist, Clinical Trial Coordinator, and specialised regulatory consultants
        • Assist the product team in ensuring product development standard operating procedures are in-line with regulatory requirements
        • Assist the design team in ensuring all medical products adhere to regulatory requirements

        Cultural Commitments

        • Passion for data-driven excellence
        • Unshakable integrity as required to work in healthcare
        • Commitment to a transparent idea meritocracy

        Requirements

        • Written and spoken fluency in English
        • Secondary education in sciences, healthcare, policy, or legal
        • Minimum one year working experience
        • Attention to detail and flair for compliance/logistics

        Recommended Assets

        • Previous experience with regulatory submissions and/or clinical trial design and/or legal affairs

        Logistics

        • Full time, starting 23Q1
        • Compensation relative to experience, with potential for options
        • Working remotely in a similar time zone

        To apply

        • Send a letter of interest and your CV by email to mi@mobiointeractive.com with the subject header "MI RAS 2023"

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