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.
This position will work with regulatory team on global regulatory strategies and submissions activities for assigned projects.
• Assist in the development of regulatory strategy for all markets and update strategy based upon regulatory changes.
• Provide regulatory input for new product development and sustaining of existing product.
• Understand, investigate and evaluate regulatory history/background of class/ disease/device/comparators in order to assess regulatory implications for approval.
• Determine and communicate submission and approval requirements.
• Participate in risk-benefit analysis for regulatory compliance.
• Assist in SOP development and review.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Write, compile, prepare, review and submit regulatory submissions to authorities.
• Monitor impact of changing regulations on submission strategies.
• Monitor applications under regulatory review and coordinate responses/respond to any questions from regulatory authorities.
• Monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Maintain annual licenses, registrations, listings and information.
• Assist with product post-marketing approval requirements.
• Review and approve complaints/MDR.
• Assist with label development and review for compliance before release.
• Submit and review changes and determine the level of change and consequent submission requirements.
• Analyze the input of cumulative product changes to current product submissions.
• Ensure product safety issues and product-associated events are adequately communicated to management.
• Provide regulatory input for product recalls and recall communications.
• Job specific responsibilities may include: Medical writing, Labeling, Gap-analysis of Standards, Region/country specific regulatory support etc.