Regulatory Affairs Specialist – Salt Lake, UT

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Responsibilities:

  • Providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified medical devices.
  • Assist in the development of the regulatory strategies for new products and design changes – ensuring regulatory requirements for target markets are met.
  • Preparing and submitting regulatory submission documents for US and OUS regulatory filings under minimal supervision for the EU and supporting outside of US (OUS) geographies.
  • Represent Regulatory Affairs on assigned project teams through all phases of product… Click here to view original post