Nevro Corp.

  • Senior Manager, Regulatory Affairs

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 3 weeks ago(6/4/2018 4:58 PM)
    ID
    2018-2218
    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 is responsible for global regulatory strategies and submissions activities for assigned projects. As a Regulatory Affairs Manager, you will collaborate with R&D, Clinical, Quality and other required functions to execute regulatory strategy from product inception to product launch.

     

    • Develop, document and implement regulatory strategies for new technologies and product modifications.
    • Prepare IDE, 510(k), PMA, CE Mark submissions and other related regulatory filings.
    • Interface with FDA, Notified Bodies, and other regulatory agencies regarding regulatory submission strategy and approval reviews.
    • Collaborate with Physicians, Clinical and Marketing to develop clinical trial plans and reports.
    • Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.
    • Provide leadership and regulatory guidance to ensure that documentation for regulatory submissions are accurate and timely to support submission timelines.
    • Establish and maintain a professional and credible image with FDA, Notified Bodies, and other regulatory agencies.
    • Maintain current knowledge of competitive technologies in addition to medical and technical developments related to the company’s products.
    • Regulatory Affairs Representative at Core Team Meetings.
    • Manage consultants and their contracts for assigned regulatory projects.
    • Review Quality System procedures for regulatory impact.
    • Ensure new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training

       

    Role Requirements

    • Bachelor's Degree in a scientific discipline
    • 8-10 yrs. experience within medical device industry in a regulatory and/or quality function. Cross-functional experience desired. 
       

    Skills and Knowledge

    • Demonstrated experience in preparing 510(k) and PMA submissions for FDA
    • Demonstrated experience with global submissions (EU, Australia, Japan, etc.)
    • Strong interpersonal and analytical skills
    • Excellent written and oral communication skills
    • Excellent organizational and multi-project management skills and attention to detail
    • Regulatory Affairs Certification (RAC) preferred

    #LI-DS1

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Connect With Us!

    Not ready to apply? Connect with us for general consideration.