**Local candidates only**

The Senior Regulatory Affairs Associate is primarily responsible for providing regulatory guidance and support, consulting with VP of Regulatory Affairs or director to establish and prepare appropriate regulatory filings for product approvals, maintaining current and in-depth knowledge of FDA, European MDR, and Worldwide Regulatory Authority programs, policies, and other critical regulatory information, assisting in the development and execution of effective regulatory affairs strategies with team representatives and with the VP of Regulatory Affairs and providing input and preparing the clinical regulatory packages.

Responsibilities:

  • Provides guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements
  • Serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
  • Assist in the development of worldwide regulatory strategies and filings for product approvals
  • Provide regulatory support to cross-functional project teams in conjunction with direct manager
  • On a project team, make decisions involving worldwide submissions and provide advice and counsel to other team members with the assistance of direct manager
  • Assist and/or prepare and submit Design Dossier technical files in compliance with the European MDR
  • Assist and/or prepare and submit FDA submissions (e.g., PMAs, 510(k)s, progress reports, device listings)
  • Assist and/or prepare dossiers for submission to worldwide regulatory agencies (e.g., Latin America, Asia Pacific)
  • Review and approve change requests and Change Orders
  • Maintain current knowledge of FDA, European and Worldwide Regulatory Authority programs, policies, and guidelines
  • Assure that all submission documentation, record keeping, and reporting meet inspection standards as established by regulatory agencies worldwide


Requirements:

  • Minimum of 7 years of medical device regulatory affairs experience in a similar or equivalent role, preferably in neuromodulation
  • Bachelors degree in engineering, science, or related disciplines: Masters degree preferred
  • Ability to develop and maintain excellent working relationships with regulatory agencies/bodies
  • Knowledge of U.S. and European medical device regulations