Dandy

Senior Counsel, Regulatory and Compliance

Dandy

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $232,500 - $243,750 per year

Job Level

Senior

About the role

  • 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

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
Benefits
  • healthcare
  • dental
  • mental health support
  • parental planning resources
  • retirement savings options
  • generous paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancemedical device regulationsinternational market entrydata privacyGDPR complianceregulatory strategy developmentlegal counselrisk managementmarket access requirementspost-market compliance
Soft Skills
communicationadvisorycollaborationproblem-solvingleadershipstrategic thinkingcross-functional teamworkproactive guidancerelationship managementorganizational skills
Certifications
JDLL.Badmitted to the barregistered in-house status