Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
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.
Bachelor's degree in science, engineering, or medical fields is preferred.
•3- 5yrs in regulatory in medical device industry with proven record of FDA/International submission and compliance experience (IDE, PMA Supplements, Technical Dossiers, Complaints/MDRs).
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Skills and Knowledge
Regulatory guidelines, policies, standards, practices, requirements and precedents. Principles and requirements of applicable product laws.
Submission/registration types and requirements.
Principles and requirements of promotion, advertising and labeling.
Domestic and international regulatory guidelines, policies and regulations.
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Effective communication skills including verbal and written is a strong must.
Must be able to communicate with diverse audiences and personnel.
Must be able to write and edit technical documents.
Must have the ability to work with cross-functional teams.
Have the ability to negotiate internally and externally with regulatory agencies
Internal Number: 2018-2081
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.