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Dandy

Senior Counsel, Regulatory and Compliance

Posted 2 Hours Ago
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Remote
Hiring Remotely in USA
Senior level
Remote
Hiring Remotely in USA
Senior level
The Senior Counsel will provide regulatory and compliance guidance, develop strategies for market access, and support international expansion for Dandy's medical devices.
The summary above was generated by AI

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

  • ISO and other international standards’ implementation experience

  • Project management experience

Req ID: J-954

For full-time positions, Dandy offers a wide range of best-in-class, comprehensive, and inclusive benefits tailored to each country where we operate. Our local benefits packages typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off—ensuring our team members are supported no matter where they live and work.

Dandy is proud to be an equal-opportunity employer. We are committed to building a diverse and inclusive culture that celebrates authenticity to win as one. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, citizenship or immigration status, or any other legally protected characteristics.

Dandy also fully complies with the Americans with Disabilities Act (ADA). We are dedicated to embracing challenges and creating an accessible, inclusive workplace for all individuals. If you require any accommodations for your interview or have any questions beforehand, rest assured that we will do everything we can to meet your needs. Visit Dandy Careers for more!

Top Skills

AI
Gdpr Compliance
Iso
Medical Devices
Ml
Saas Software

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