Description:

Dandy is transforming the massive and antiquated dental industry—an industry worth over $200B. Backed by some of the world's leading venture capital firms, we're on an ambitious mission to simplify and modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world-class support to achieve more for their practices, their people, and their patients.

About the role:
Dandy's approach to providing the operating system for dentists involves a number of critical components - efficient human operations, medical devices, ML/AI, sophisticated 3D computer vision and cutting-edge SaaS software. Dandy is hiring a skilled and deeply business-minded Senior Counsel, Regulatory and Compliance to help drive not only the company's legal function (including regulatory, international market access, ISO, privacy, and other domestic and international compliance matters) but also to support meaningful cross-functional project management on globalization matters by providing commercially savvy guidance to, and being a core member of, Dandy's international expansion / globalization team from the perspective of legal, regulatory, and compliance risks and opportunities.

What You'll Do:

Serve as Dandy's primary regulatory and compliance counsel, providing proactive, practical guidance across the business and acting as a trusted advisor to founders, the executive team, and cross-functional leaders on regulatory risk and compliance matters.
Develop regulatory and compliance strategy for Dandy's medical device portfolio across domestic and international markets, ensuring ongoing compliance with applicable federal, state, local, and global regulations.
Be a core member of Dandy's international expansion and globalization efforts, developing and executing regulatory and compliance plans to support new market entry and global growth.
Lead and support new market launches, including hands-on involvement in multiple international market entries and advising on global market access requirements.
Act as the front-line resource for identifying, interpreting, and applying applicable global and local laws, regulations, standards, and guidance to business activities.
Develop and draft market-specific regulatory strategies in close partnership with Product, Quality, Operations, Manufacturing, R&D, Commercial, and other stakeholders.
Implement and maintain regulatory compliance structures and processes across the business, with a particular focus on medical device regulatory frameworks
Serve as the primary point of contact with domestic and international regulatory agencies, managing routine communications, administrative matters, inspections, and escalations
Provide guidance on marketing and post-market compliance, including AKS/referral considerations, advertising and promotion requirements, and post-market obligations.
Advise on and support data privacy and GDPR compliance as applicable to international operations

What We're Looking For:

7+ years of experience as a lawyer generally
4+ years medical device experience required
4+ years of experience in a regulatory legal or compliance legal role required, public company experience a plus
3+ years of experience in-house at a tech company, a plus, health start-ups preferred
Demonstrated hands-on experience supporting international new market launches, preferably across multiple regions and markets.
Experience acting as the direct point of communication with U.S. and international regulatory agencies and Notifying Bodies, including routine interactions and escalations.
JD, LL.B, or equivalent degree and admitted to the bar and in good standing or otherwise authorized to practice law (e.g., have registered in-house status) in the state in which the position is located

Bonus points for: