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Regulatory Affairs Lead

  • Location

    Palo Alto

  • Salary

    US$160000.00 - US$200000.00 per year + Equity

  • Sector


  • Job Ref


  • Contact

    Daniel Boyce

  • Published

    6 days ago


Join a dynamic company at the forefront of AI-driven healthcare innovation. We are seeking a Regulatory Strategy Manager to play a pivotal role in designing and executing regulatory strategies for AI algorithm development and commercialization in the healthcare sector. Make a difference by helping doctors catch deadly diseases earlier through the adoption of artificial intelligence.

About the Role: You will be responsible for developing sustainable processes and ensuring timely regulatory submissions, with a focus on securing FDA clearance for a steady pipeline of software as a medical device (SaMD) applications via the 510(k) process. This unique opportunity allows you to engage with a wide variety of AI-based SaMD developed by leading academic researchers.


  • Define and execute regulatory strategies for securing FDA clearance of SaMD applications.
  • Ensure compliance with current regulations and guidance.
  • Lead the preparation and compilation of regulatory submission documents.
  • Coordinate cross-functional teams for input collection and organization.
  • Develop innovative regulatory solutions aligned with company goals.
  • Provide regulatory expertise to project teams for strategy alignment.
  • Establish and manage a Quality Management System (QMS) for medical device development.
  • Represent the company in FDA communications and meetings.
  • Design, track, and manage metrics for regulatory submission processes.

Skills and Qualifications:

  • 4+ years of professional experience in medical device regulatory industry.
  • Bachelor's or advanced degree in a relevant field.
  • Strong preference for experience with software as a medical device (SaMD) 510(k) submissions involving artificial intelligence.
  • Demonstrated success in securing FDA clearance for medical devices.
  • Proven track record of executing projects in a corporate environment.
  • Excellent organization skills and attention to detail.