Head of Regulatory Strategy & Clinical Development

Job Description

Job Description

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.

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.

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.

• 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

• 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.

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.