Head of Regulatory

Lead the Future of Dentistry. Overjet is the world-leader in dental AI. Already, thousands of dental providers and insurers rely on our platform to deliver the best possible care. Now, we’re looking for talented people to fulfill our mission: improve oral health for all. Overjet is where builders become leaders. Everyone here loves to make new things: new products, new partnerships, new content, and a new category of AI technology. And as Overjet grows ridiculously fast, so will you. Simply put, there’s no better place to accelerate your career. Come join us! The Role Overjet is looking for a Head of Regulatory to own the critical regulatory function at a growing Healthtech AI company. As a key member of the Engineering team, reporting to our VP of Machine Learning & Compliance. This is an incredible opportunity to help lead the future of dental care — by building and leading the regulatory function as we scale. Responsibilities - Develop, lead, and execute Overjet’s global regulatory strategy, ensuring alignment with business goals and evolving international requirements. - Own the planning, coordination, and submission of regulatory filings, including FDA 510(k), De Novo, Health Canada Medical Device License (MDL), EU MDR (via SGS NB and Casus EU RP), UK MHRA registration (via Casus UK RP), and Australian TGA (via sponsor Emergo by UL). - Serve as the primary point of contact with regulatory authorities (e.g., FDA, Health Canada, MHRA, TGA, EU Notified Bodies) for product approvals, QMS compliance, and ongoing reporting. - Interpret and communicate new or evolving global regulatory requirements across internal stakeholders, and incorporate them into Overjet’s regulatory and quality systems. - Partner with Product, Clinical, Engineering, and QA teams to ensure regulatory requirements are embedded throughout the product lifecycle—including design controls, validation, verification, and risk management. - Manage development and maintenance of submission-ready documentation and regulatory dossiers. - Provide regulatory input for clinical studies, real-world evidence programs, and data usage strategies. - Collaborate with the VP of Machine Learning & Compliance and Director of Security to align regulatory strategies with privacy, cybersecurity, and AI risk management frameworks. - Support regulatory due diligence for partnerships, audits, and customer-facing compliance engagements. - Lead inspections and audits from regulatory authorities and Notified Bodies, and ensure timely resolution of findings. - Build and manage the regulatory team as Overjet scales globally. Qualifications - 7+ years of experience in regulatory affairs for medical devices, including 2+ years with software as a medical device (SaMD) under FDA and at least one international regulatory framework (e.g., Health Canada, EU MDR, MHRA, TGA). - Proven success managing regulatory submissions and approvals in multiple jurisdictions (e.g., FDA 510(k), De Novo, CE Marking, MDEL, UK MHRA registration, TGA conformity assessments). - Deep knowledge of global regulatory frameworks including: - U.S. FDA (21 CFR Part 820, SaMD guidance) - Canada’s Medical Devices Regulations - EU MDR and IVDR (including Notified Body processes) - UK Medical Device Regulations - Australian TGA (including sponsor model) - Experience interacting directly with agencies and notified bodies, including leading meetings and responses to questions or deficiencies. - Expertise in ISO 13485, ISO 14971, and IEC 62304; familiarity with ISO 27001 and data protection standards (HIPAA, GDPR) a plus. - Strong knowledge of quality management systems and compliance audits, including internal and external inspection readiness. - Excellent communication skills, including the ability to translate technical and regulatory language for cross-functional teams. - High degree of ownership, self-direction, and comfort working in fast-paced, high-growth environments. - Bachelor's degree in a scientific or engineering…