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.
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. 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
Internal Number: 2018-2218
About Nevro Corp
Headquartered in Redwood City, California, Nevro is a global and rapidly expanding public medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain.