Head of Regulatory Strategy & Clinical Development
$160k - $195k USD
About Eyebot
Eyebot is an outcome-focused technology company on a mission to make vision care accessible to everyone, equally. Headquartered in Boston’s North End and backed by top investors and the National Science Foundation, our vision test kiosk is reshaping how vision care is delivered.
If you are passionate about solving big problems and building the future of vision care, we would love to hear from you.
About the Role
Eyebot is looking for a Head of Regulatory Strategy & Clinical Development to own our path to market. You'll define and execute FDA regulatory strategy for our AI-enabled ophthalmic diagnostic platform, including 510(k) submissions, Pre-Subs, and CE marking under EU MDR while leading the clinical evidence strategy that supports it. This is a hands-on leadership role with direct executive visibility and a direct line to product impact.
What You’ll Do:
U.S. FDA Strategy
Define and execute overall FDA regulatory strategy, including predicate selection, intended use framing, and risk positioning
Author and lead Pre-Submission and 510(k) filings from first draft through clearance
Serve as Eyebot's primary point of contact for FDA meetings, Q-Subs, and official correspondence
Align risk management, labeling, and software documentation with FDA expectations under applicable device software guidance
EU CE Marking
Lead EU MDR regulatory strategy and own the CE marking pathway end-to-end
Develop and maintain the Technical File; manage Notified Body interactions and audits
Oversee post-market surveillance and vigilance strategy; ensure alignment between U.S. and EU regulatory positions
Clinical Strategy & Execution
Determine when clinical evidence is required and define scope of evidence needed
Design clinical study protocols and statistical analysis plans
Oversee IRB submissions, site coordination, study execution, data quality, and final study reports
Program & Cross-Functional Leadership
Own regulatory program timelines across hardware, software, clinical, and labeling workstreams
Provide regulatory guidance to engineering and product teams throughout development
Present regulatory strategy, risk assessments, and timelines to executive leadership
Ensure alignment with ISO 14971 risk management and applicable device standards
This is a hybrid role based out of our North End or Charlestown offices in Boston . We work together in person 4–5 days per week - we find the energy and collaboration of being together in person makes a real difference, especially at this stage of the company.
What We’re Looking For:
6–12 years of medical device regulatory experience
Proven, hands-on ownership of successful 510(k) submissions - you wrote them, you led them
Direct experience with EU MDR and the CE marking process
Experience leading or preparing FDA Q-Sub or Pre-Sub meetings
Background with Class II diagnostic or electromechanical devices
Strong regulatory writing and documentation skills
Familiarity with device software and current FDA guidance in this area (SaMD, AI/ML)
Ophthalmic device experience strongly preferred
Who You Are:
You're a builder, not just an operator - you're energized by creating regulatory infrastructure from scratch rather than inheriting it
You own your work end-to-end - you've personally authored submissions, not just supported them
You communicate clearly with both technical teams and executives - you can translate regulatory complexity without oversimplifying it
You're comfortable with the pace and ambiguity of an early-stage company - you know how to prioritize when everything feels urgent
What We Offer:
Compensation: $160,000–$195,000 base salary, commensurate with experience
Meaningful equity - you're building this with us and should share in what we create
Flexible work schedule with unlimited PTO - we care about the work you do, not the hours you log
Health, dental, and vision insurance
Employer-sponsored 401(k)
Commuter support and wellness benefits - including tools like Calm and Cariloop to help you perform at your best
A culture where all ideas are welcome, no matter how out there — that's how Eyebot started, and it's how we keep moving forward
A collaborative office in Boston's North End, with regular team lunches and a waterfront view
The opportunity to build products that improve lives and reshape how vision care is delivered.
Apply - Even If You're Not Sure
We know that job descriptions can feel like long checklists, and that talented people sometimes talk themselves out of applying. If you're excited about this role and the mission but don't meet every single requirement, we still want to hear from you. Eyebot is committed to building a diverse and inclusive team, and we welcome applicants of all backgrounds, identities, and experiences.
Eyebot is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.