About the job
About Eyebot
Eyebot is a visionary technology firm dedicated to revolutionizing vision care accessibility for all. Based in the vibrant North End of Boston and supported by esteemed investors and the National Science Foundation, our innovative vision test kiosk is transforming the delivery of vision care.
If you are driven by the passion to tackle significant challenges while helping to shape the future of vision care, we eagerly invite you to connect with us.
About the Role
We are seeking a dynamic Head of Regulatory Strategy & Clinical Development to chart our market approach. In this pivotal role, you will craft and implement the FDA regulatory strategy for our cutting-edge AI-powered ophthalmic diagnostic platform, managing 510(k) submissions, Pre-Submissions, and CE marking compliance under the EU MDR. This leadership position offers direct visibility to executives and significant influence over product outcomes.
Your Responsibilities:
U. S. FDA Strategy
Establish and execute comprehensive FDA regulatory strategies, including predicate selection, intended use definition, and risk assessment.
Lead the drafting and submission of Pre-Submission and 510(k) applications from inception to clearance.
Act as the primary liaison for all FDA interactions, including meetings, Q-Submissions, and formal communications.
Ensure risk management, labeling, and software documentation align with FDA guidelines.
EU CE Marking
Direct the EU MDR regulatory strategy and manage the CE marking process comprehensively.
Create and uphold the Technical File; facilitate interactions and audits with Notified Bodies.
Monitor post-market surveillance and vigilance, ensuring consistency between U. S. and EU regulatory perspectives.
Clinical Strategy & Execution
Identify when clinical evidence is necessary and specify the required evidence scope.
Design and implement clinical study protocols and statistical analysis plans.
Oversee IRB submissions, site coordination, study execution, data integrity, and final reporting.
Program & Cross-Functional Leadership
Manage regulatory program timelines across hardware, software, clinical, and labeling workflows.
