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    Senior Regulatory Affairs Specialist - Irvine, United States - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Irvine, United States

    3 weeks ago

    Intellectt Inc background
    Description

    Role: Sr Spec, Regulatory Affairs

    Location: Irvine, CA

    Duration: 9+ Months on W2

    Job Description:

    Key Responsibilities:


    • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).


    • Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.


    • Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.


    • Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.


    • Other incidental duties assigned by Leadership.

    Additional Skills:


    • Coursework, seminars, and/or other formal government and/or trade association training required


    • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel


    • Good written and verbal communication skills and interpersonal relationship skills


    • Good problem-solving, organizational, analytical and critical thinking skills


    • Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices


    • Solid knowledge and understanding of global regulatory requirements for new products or product changes.

    Education and Experience:


    • Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)


    • 5-7 years of experience required

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