The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory, and business issues to enable products that are developed to meet required regulatory requirements. The individual may identify information needed, obtain data and ensure that the information is effectively presented for the registration of products worldwide.  

The Principal Regulatory Affairs Specialist should also have the experience in regulatory compliance to provide effective direction and guidance to R&D, manufacturing, and marketing/sales regarding changing regulatory requirements and standards.

This position reports to the VP of Regulatory and Quality Assurance.



  • Lead in writing, and preparing regulatory submissions and filings required for U.S. FDA and other regulatory bodies (e.g. Notified Bodies for CE marking, Health Canada Licenses, etc.) as needed
  • Evaluate changes to products for impact on global regulatory approvals
  • Lead effort to monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
  • Support product development teams with regards to implementation of international regulatory requirements

Post market

  • Oversee processes involved with maintaining annual licenses, registrations, listings
  • Work with management to ensure compliance with product post marketing approval requirements
  • Work with the internal team for assessment of product reporting/recall activities
  • Work with the appropriate internal groups to report adverse events to regulatory agencies and internal stakeholders
  • Maintain and update regulatory affairs procedures and changes
  • Help with continuous improvement of the submission process


  • Bachelor’s degree in a scientific discipline; advanced degree preferred; RAC (Regulatory Affairs Certificate) desired
  • Five or more years’ experience in medical device regulatory affairs with direct project management responsibilities
  • Experience in leading the development, writing and submittal of successful 510(k)/PMA/De Novo submissions
  • Must have prior working experience with application processes for 510(k)s, Health Canada Applications and CE Mark applications and technical files
  • Working knowledge of ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820
  • Knowledge of software development as it relates to regulatory submissions a plus
  • Knowledge of electromechanical medical devices, or complex software-driven medical devices is required
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Excellent oral and written communication skills
  • Excellent attention to detail
  • Excellent organizational and negotiation skills
  • Ability to work independently as an individual contributor and in a team environment
  • Requires ability to work on-site in Hayward, CA

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