Director of Regulatory Strategy & Clinical Development

EyebotBoston

On-site Full-time $160K/yr - $195K/yr

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Experience Level

Senior Level Manager

Qualifications

Qualifications:Proven experience in regulatory affairs, particularly with FDA and EU regulations. Demonstrated expertise in clinical development and evidence generation. Strong leadership skills with experience in cross-functional team management. Excellent communication skills, both verbal and written. Ability to think strategically while managing operational details.

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.

About Eyebot

Eyebot is committed to transforming the accessibility of vision care through innovative technology. Our mission is to ensure that quality vision care is available to everyone, and our advanced vision test kiosks are at the forefront of this change.

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Senior Product Manager - Veeva Clinical Operations

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Veeva Systems Inc. is a forward-thinking organization and a leader in cloud solutions for the life sciences sector, dedicated to accelerating the process of bringing new therapies to patients. As one of the fastest-growing SaaS companies globally, we achieved over $2 billion in revenue last fiscal year and are poised for further growth.At Veeva, our core values drive us: We prioritize doing the right thing, achieving customer success, fostering employee success, and ensuring speed in our operations. In 2021, we made history by becoming a public benefit corporation (PBC), which legally commits us to balance the interests of our customers, employees, society, and investors.As a Work Anywhere company, we empower you to choose your work environment, whether from home or the office, to help you thrive in your preferred setting.Join us on our mission to transform the life sciences industry and make a meaningful impact on our customers, employees, and the communities we serve.

Sep 23, 2025

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