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Chelsea O'Connell

Chelsea O'Connell

Engineer I

Followers of Chelsea O'Connell1000 followers
location of Chelsea O'ConnellVentura, Califórnia, Estados Unidos

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  • Timeline

  • About me

    US Lead, Global Regulatory Policy & Intelligence at Amgen

  • Education

    • California Polytechnic State University-San Luis Obispo

      -
      MS Biomedical Engineering

    • California Polytechnic State University-San Luis Obispo

      -
      BS Biomedical Engineering

  • Experience

    • Alcon

      Jan 2009 - Jan 2010
      Engineer I

    • Amgen

      Jan 2011 - now

      US/Global Regulatory Policy- Real World Evidence - Innovative Clinical Trials- Medical Devices/Diagnostics Regulatory lead for programs including medical devices - companion diagnostics, combination products, software, wearables, and closed system transfer devices

      • US Lead, Global Regulatory Policy & Intelligence

        Jan 2024 - now

      • Director, Global Regulatory and R&D Policy

        Jan 2021 - Jan 2024

      • Senior Manager, Regulatory Affairs

        Nov 2014 - Jan 2021

      • Senior Engineer

        Jan 2011 - Nov 2014

  • Licenses & Certifications

    • Regulatory Affairs Certification (RAC)

      Regulatory Affairs Professionals Society (RAPS)
      Jun 2014