Nevro Corp.

  • Regulatory Specialist I (Temp-to-Hire)

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 3 weeks ago(6/4/2018 4:57 PM)
    ID
    2018-2219
    Category
    Regulatory
  • About Nevro

    Nevro (NYSE: NVRO) is a public multinational medical technology company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform.

     

    We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 28,000 patients around the world.

     

    The Nevro® Senza® SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.

    Overview

    Support regulatory submissions and regulatory compliance for product development process.

     

    • Represents Regulatory Affairs on cross-functional teams for clinical research projects.
    • Prepares annual progress reports, protocols and clinical study reports for submission to regulatory authorities.
    • Assists in the preparation and submission of regulatory applications, as well as maintains internal regulatory file documentation.
    • Tracks and maintains approvals, registrations and licenses for US and OUS regulatory requirements.
    • Conducts literature searches to support regulatory requirements.
    • Maintains library of all publications pertinent to the Company.
    • Supports and maintains Quality initiatives in accordance with Nevro Quality Policy.
    • Supports clinical research initiatives (protocol/CRF review, IRB submissions etc.)
    • Supports complaint and MDR review.
    • Other duties as assigned.

    Role Requirements

    • Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
    • 1-2 years of experience in biotech and/or medical device industry recommended
       

    Skills and Knowledge

     

    •  Knowledge of medical device regulations is recommended.
    • 1-2 years of experience in biotech and/or medical device industry recommended.
    • Ability to manage several projects.
    • Proficiency with Microsoft Office.
    • Effective research and analytical skills.
    • Effective written and oral communication, technical writing and editing skills.
    • Ability to work independently with minimal supervision.

    #LI-DS1

     

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