Senior Counsel, Regulatory and Compliance
RemoteSeniorNADentalMedical DevicesMental HealthCompliance CounselLawyerSenior AdvisorExecutive SupportRegulatory ComplianceCloseGDPR Compliance
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Requirements
- 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
- ISO and other international standards’ implementation experience
- 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.
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
Benefits
- $232,500 – $243,750 • Offers Equity • Offers Bonus
- Actual compensation for roles will vary based on factors including the candidate's location, skills, qualifications, and experience.
- Please note that compensation listed for U.S. based roles applies only to candidates working in the United States. Candidates hired outside the U.S. will receive regionally adjusted compensation.
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