Dandy · 20 hours ago
Senior Counsel, Regulatory and Compliance
Dandy is transforming the dental industry through technology and innovation. They are seeking a Senior Counsel, Regulatory and Compliance to provide legal guidance on regulatory risk and compliance matters, support international expansion, and ensure compliance with applicable regulations across markets.
Artificial Intelligence (AI)CADDentalHealth CareIndustrial AutomationLogisticsManufacturingSoftware
Responsibilities
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
Qualification
Required
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
Preferred
ISO and other international standards' implementation experience
Project management experience
Benefits
Healthcare
Dental
Mental health support
Parental planning resources
Retirement savings options
Generous paid time off
Company
Dandy
More than a dental lab—Dandy is a tech-powered, end-to-end solution delivering high-quality, customized restorations at scale.
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
GreenoaksPrimary Venture Partners
2025-05-02Series D
2022-08-17Series C
2022-01-20Series B
Leadership Team
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