Regulatory Strategy and Execution

About Bunkerhill Health

Bunkerhill Health is the commercialization engine for healthcare AI

Tech description:

Job description:

## About the role

Bunkerhill is a Sequoia-backed company whose goal is to help academic researchers bring their healthcare AI algorithms to widespread clinical use. Success for our company requires that we secure more FDA clearances per year for algorithms than any other company ever has. We are looking for a talented and strategically-minded problem solver to join our growing team in our office in SoMa in SF. You will be responsible for understanding regulatory guidance and requirements and developing and executing plans to maximize the pace at which we secure clearance for the algorithms in our pipeline.

Responsibilities:

- Develop and implement high-level regulatory strategy: Drive short- and long-term plans to optimize the pace and efficiency of FDA clearance for Bunkerhill's AI algorithms.
- Analyze and interpret complex regulatory guidance: Deeply understand FDA requirements and the evolving landscape for AI in healthcare, identifying potential pathways for approval.
- Design and manage submission plans: Create strategic timelines and resource allocation for algorithms within the pipeline, prioritizing based on potential impact and feasibility.
- Lead cross-functional collaboration: Partner with engineering, internal stakeholders, and external researchers and clinicians to gather necessary data, prepare documentation, and navigate the clearance process.
- Identify and mitigate regulatory risks: Proactively assess potential hurdles and develop strategies to address them before impacting progress.
- Build and maintain strong relationships: Foster positive partnerships with external regulatory agencies and relevant industry stakeholders.
- Track and evaluate regulatory trends: Actively monitor evolving regulations and industry advancements to inform strategic decision-making.
- Analyze and optimize internal processes: Identify bottlenecks and opportunities to streamline internal procedures for faster approvals.
- Measure and report on regulatory performance: Track key metrics and KPIs, regularly reporting progress and providing data-driven insights to leadership.

Qualifications:

- **Note: direct regulatory experience is not required for this role**
- Demonstrated success in a role with heavy exposure to structured, strategic problem solving (e.g., management consulting).
- (Strongly preferred) Experience in healthcare or healthcare-related fields, understanding of AI concepts and development processes, strong technical understanding (prior exposure to coding in some capacity is a plus).
- Excellent communication and collaboration skills: Ability to clearly articulate complex concepts to both technical and non-technical audiences, and build strong relationships across teams.
- Analytical and research skills: Proven ability to gather and analyze information, assess data, and draw actionable conclusions.
- Attention to detail and accuracy: Ability to handle meticulous tasks with a strong focus on precision and thoroughness.
- Proficiency in relevant software tools: expert-level skills in Powerpoint (for FDA-facing presentations) and Word (for creating FDA-submission-ready documents)