Regulatory Affairs Lead

Bunkerhill Health is a Sequoia-backed company on a mission to facilitate and streamline the AI development efforts of academic researchers and to increase the adoption of AI in healthcare in order to help doctors catch deadly diseases earlier.

We have built a consortium of research institutions (Stanford, Johns Hopkins, UCSF, Harvard, etc.) whose researchers develop and validate AI algorithms seamlessly under our legal umbrella (weeks of setup time for a new project when using the Bunkerhill consortium, versus a year or more for projects outside the consortium). Bunkerhill then manages the FDA clearance and commercial sales process for the algorithms that these institutions develop and validate through the consortium.

We’ve signed commercial contracts and deployed algorithms with some of the world’s leading health systems — UCSF, Mayo Clinic, Georgetown/MedStar, and several others. These algorithms help doctors identify patients earlier than has otherwise been possible, leading to better treatment outcomes (early clinical screening for heart disease, pancreatic cancer, etc.).

We’re backed by world-class investors, including Sequoia, Max Levchin (co-founder of PayPal and Affirm), and Y Combinator.

We’re looking for a strong candidate to be responsible for the design and execution of regulatory strategies for AI algorithm development and commercialization. This individual will build sustainable processes and execute the work to ensure the timely and effective completion of regulatory submissions, with a particular emphasis on securing FDA clearance for a steady pipeline of software as a medical device (SaMD) applications through the 510(k) process. As Bunkerhill’s algorithms are not developed in-house and are instead sourced from the broader research community, this role will offer an opportunity to engage with an unparalleled variety and quantity of AI-based SaMD.

Offer will include base salary and equity.

Responsibilities:

• Define and execute regulatory strategy to ensure a sustainable, timely process for securing FDA clearance for a steady pipeline of software as a medical device (SaMD) applications through the 510(k) pathway
• Ensure compliance of regulatory strategies and submissions with current regulations and guidance
• Lead the preparation and compilation of documents and supporting appendices for regulatory submissions
• Coordinate efforts across cross-functional teams to collect and organize inputs required for regulatory submissions
• In alignment with broader company strategy and goals, develop and provide innovative regulatory solutions to address complex issues
• Bring regulatory expertise to project teams to ensure alignment between project elements (e.g., pivotal study design) and regulatory strategy
• Establish and manage a Quality Management System (QMS) for the development and improvement of all medical devices in Bunkerhill’s development and commercialization pipeline
• Represent Bunkerhill in communications and meetings with the FDA
• Design, track, and manage metrics to provide visibility into the speed and effectiveness of the regulatory submission and clearance process

Skills and qualifications:

• 4+ years of professional experience in medical device regulatory industry
• Bachelor’s or advanced degree in relevant field
• (Strongly preferred) Direct experience with preparing or reviewing software as a medical device (SaMD) 510(k) submissions, preferably those that involve artificial intelligence
• Demonstrated success in preparing submissions and securing FDA clearance for a variety of medical devices
• Demonstrated experience developing strategy and executing projects to drive quantifiable results in a corporate environment
• Superb organization skills and attention to detail