Senior Counsel, Regulatory and Compliance

Overview

A company transforming the dental industry is seeking a Senior Counsel, Regulatory and Compliance to lead legal functions related to regulatory, international market access, ISO, privacy, and compliance matters. This role supports cross-functional project management for globalization efforts, providing commercially savvy legal guidance as part of the international expansion team.

Responsibilities

• Serve as primary regulatory and compliance counsel, advising founders, executives, and cross-functional leaders on regulatory risk and compliance.
• Develop regulatory and compliance strategies for the medical device portfolio across domestic and international markets.
• Participate as a core member of international expansion efforts, developing and executing regulatory plans for new market entry and global growth.
• Lead and support new market launches, including multiple international market entries and advising on global market access requirements.
• Identify, interpret, and apply global and local laws, regulations, standards, and guidance to business activities.
• Collaborate with Product, Quality, Operations, Manufacturing, R&D, Commercial, and other teams to develop market-specific regulatory strategies.
• Implement and maintain regulatory compliance structures and processes, focusing on medical device regulatory frameworks.
• Act as primary contact with domestic and international regulatory agencies, managing communications, inspections, and escalations.
• Provide guidance on marketing and post-market compliance, including anti-kickback statute/referral considerations, advertising, promotion, and post-market obligations.
• Advise on data privacy and GDPR compliance relevant to international operations.

Requirements

• 7+ years of legal experience.
• 4+ years of medical device experience.
• 4+ years in a regulatory or compliance legal role; public company experience is a plus.
• 3+ years in-house experience at a technology company preferred; health start-up experience is a plus.
• Demonstrated hands-on experience supporting international new market launches across multiple regions.
• Experience as direct point of contact with U.S. and international regulatory agencies and Notifying Bodies.
• JD, LL.B, or equivalent degree; admitted to the bar and in good standing or authorized to practice law in the relevant jurisdiction.

Preferred Qualifications

• Experience implementing ISO and other international standards.
• Project management experience.

Compensation & Benefits

Full-time positions offer comprehensive and inclusive benefits tailored to each country of operation. Typical benefits include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off.

Location

Position location details are not specified.