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Regulatory Affairs Professional 3

  • Location

    Tarrytown, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    20012

  • Published:

    over 1 year ago

  • Expiry date:

    2020-06-04

? Writing, reviewing and approving technical reports for regulatory submissions for in vitro diagnostic devices ? Notifying country regulatory colleagues of impending design changes and summarizing global regulatory requirements ? Preparing regulatory submission packages

Required Knowledge/Skills, Education, and Experience ? BS/BA in scientific discipline, or advanced degree, where required, or equivalent combination of education and experience. ? Minimum 2 - 4 years medical device/in vitro diagnostics assay development and/or regulatory experience ? Experienced in writing, reviewing and approving technical reports for regulatory submissions ? Experience with U.S. FDA submissions and knowledge and experience with global registrations of in vitro diagnostic devices a plus

Contract is for 1 year