Nevro Corp.

  • Senior Director, Regulatory Affairs

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 1 month ago(10/14/2018 8:11 PM)
    ID
    2018-2408
    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 36,000 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

    Responsible for all aspects of regulatory affairs, including strategic and operational leadership relative to the direction, planning, execution and conduct of Nevro’s regulatory objectives.  Ensure compliance with applicable regulations and SOPs, and in accordance with expected timelines and budgets.  Provides functional leadership, management and development to the others within the Regulatory Department. This is a hands-on position.

     

    • Prepare and execute worldwide regulatory strategies/plans, both short term and long range.
    • Manage regulatory team with oversight for day to day department responsibilities
    • Lead and participate regulatory strategy formulation working closely with Clinical, Market Access, R&D, and Quality teams
    • Generate or direct regulatory affairs specialists in the preparation of submissions (i.e. PMA, 510(k), PMA supplements, CE marking applications, product registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals.
    • Present project updates during team meetings and updates to senior management
    • Provide on-going support to product development
    • Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes.
    • Review and provide input to labeling and marketing programs in reference to regulatory requirements.
    • Keep abreast of new or developments in various regulations and advice senior management as necessary.
    • Interface with regulatory agency representatives as needed to accomplish the above tasks.
    • Other duties as assigned.


     

    Role Requirements

    • 8-10+ years of progressive and demonstrably successful regulatory experience leading to successful regulatory clearances/approvals and product launches
    • Must have supervisory experience of professionals.
    • B.S. in scientific discipline or engineering


     

    Skills and Knowledge

    • Good working knowledge of U.S. FDA, Canada and EU regulations and standards.
    • Broad working knowledge of GCP, GMP, GLP
    • Excellent interpersonal, communication (written and oral), teamwork, leadership, organizational and negotiating skills.
    • Ability to execute complex, multi-disciplinary projects and related activities coupled with strong analytical skills
    • Effective oral and written communication, interpersonal & influencing skills.
    • PC skills, including word processing, spread sheets, project management, etc.

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