Nevro Corp.

  • Regulatory Affairs Intern

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 3 weeks ago(12/27/2018 12:02 PM)
    ID
    2018-2491
    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

    This position will be responsible for maintenance of US & OUS regulatory files and publication library. This position will also be responsible for providing support to the regulatory team in preparing submission. In addition, the intern will be spending a lot of time helping us get prepared for the new EU MDRs, I see BSI kind of pushing companies to start implementing the regulations even sooner than deadline. This position works directly with regulatory.

     

    • Supports Regulatory personnel in the preparation of submissions for the FDA and Notified Body.
    • Conducts literature searches to support regulatory requirements.
    • Conduct MAUDE database searches.
    • Performs special projects as required.
    • Support Database Management projects.
    • Help with EU new MDRs.
    • Assists with printing and filing regulatory submission documents.
    • Review Internal SOPs and documents for clarification and completeness.

    Role Requirements

    • Working towards Bachelor’s or Master’s degree in relevant discipline

    Skills and Knowledge

    • Knowledge of medical device regulations is helpful.
    • Experience in biotech and/or the device industry preferred.
    • Ability to plan and schedule multiple priorities in a concurrent fashion.
    • Ability to review, collate and summarize scientific and technical data.
    • Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.
    • Excellent problem solving and analytical skills.
    • Good written and oral communication skills.
    • Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy.
    • Complete work with minimal supervision and ability to work independently.

     

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    Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.

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