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    Head of Regulatory Affairs and Quality Assurance - Bedford, United States - Genabio Diagnostics

    Genabio Diagnostics
    Genabio Diagnostics Bedford, United States

    1 week ago

    Default job background
    Upper Management / Consulting
    Description

    Position Overview:

    The employee works with the management team to


    • Oversee quality and legislative requirements of all products and services


    • Work with contractors and regulatory agencies for product approval and life cycle management


    • Manage regulatory and technical team

    Required Education, Skills and Experience:


    • Minimum of a bachelor's degree in a life scientific field such as Biochemistry, Biotechnology, Pharmacy, Medicinal chemistry, or Biomedical science


    • Minimum of 5 years of experience in a similar role


    • Excellent verbal and written communication skills


    • Strong problem-solving skills


    • Highly developed attention to detail


    • Strong project management skills


    • Proficiency in Chinese

    Essential Functions/Responsibilities

    Regulatory Affairs:


    • Ensuring products in compliance with 510K regulations set by the Regulatory Agency


    • Composing product, scientific and legal documents


    • Working with others in the company on various products for technical and regulatory related matters


    • Planning, undertaking and overseeing 510K clinical trials and FDA regulatory inspections


    • Keeping up to date with changes in regulatory legislation and guidelines


    • Obtaining marketing permission


    • Liaising and negotiating with regulatory authorities


    • Providing advice about regulations to manufacturers/scientists


    • Ensuring that quality standards are met, and submissions meet strict deadlines



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