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. We are looking for a talented and experienced regulatory specialist to join our growing team.
Responsibilities:
- Lead 510k submission process for radiology and cardiology AI-based SaMD devices: Manage all aspects of 510k preparation, including data analysis, technical writing, safety assessments, and communication with the FDA.
- Conduct gap analyses and risk assessments: Identify differences between the device and predicate devices, and evaluate the potential risks associated with the device.
- Develop and maintain strong relationships with cross-functional teams: Collaborate effectively with internal and external stakeholders to gather information and inputs to ensure a smooth submission process.
- Stay up-to-date on regulatory changes: Actively track and interpret FDA guidance documents and regulations relevant to AI-based SaMD devices.
- Prepare and deliver presentations on regulatory requirements: Explain complex regulatory concepts to internal stakeholders and external audiences.
- Manage regulatory document control: Ensure all related documents are properly versioned, archived, and readily accessible.
- Respond to FDA inquiries and requests for information: Provide timely and accurate responses to any FDA questions during the review process.
- Track and communicate submission progress: Keep stakeholders informed of the status of the 510k submission and potential timelines.
- Develop and implement internal regulatory processes: Contribute to the improvement of internal processes for compliance with regulatory requirements.
- Identify and manage regulatory risks: Analyze potential risks associated with the device and propose mitigation strategies.
Qualifications:
- Bachelor's degree in a relevant field, such as engineering, biology, healthcare administration, or regulatory affairs.
- Minimum of 2-3 years of direct experience in preparing and submitting 510k submissions for AI-based SaMD devices, preferably in radiology and/or cardiology.
- Strong understanding of FDA regulations governing AI-based SaMD devices and relevant guidance documents.