Nevro Corp.

Regulatory Affairs Intern

US-CA-Redwood City
4 weeks ago(12/21/2017 6:58 PM)
ID
2017-1996
Category
Regulatory

About Nevro

Nevro is a medical device company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform for the treatment of chronic pain.

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 advanced the state of spinal cord stimulation (SCS).

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.

 

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.