Head of Regulatory

The posting, as Overjet wrote it

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. 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 k

[…]
st Places to Work by BuiltIn lists in 2026 https://www.linkedin.com/posts/overjet_were-incredibly-proud-to-share-that-overjet-activity-7414346196640718848-cFGG?rcm=ACoAAChRVxsB6jrIO04hl4zDCmIVA0qDSepyiRA&utm_medium=member_desktop&utm_source=share: #3 overall in the US, #1 in NYC, #1 in San Francisco, and #2 in Boston

• #4 on FastCompanys's Most Innovative Companies list in Healthcare for 2026 https://www.fastcompany.com/91497221/healthcare-most-innovative-companies-2026
• Named one of the TIME Best Inventions of 2024 https://www.overjet.com/blog/overjet-named-to-time-best-inventions-of-2024
• Recognized in Newsweek’s Most Loved Workplaces in America 2024 https://www.newsweek.com/top-20-most-loved-workplaces-america-2024-1960025
• Won the Dental Health category at the Digital Health Awards 2024 https://www.digitalhealthhub.org/awards/2024/2024-winnersand 2024 Best Places to Work by Built In https://www.overjet.com/blog/overjet-is-one-of-built-in-s-best-startups-to-work-for-in-2024
• Recognized as one of the Top Startups of 2023 by LinkedIn https://www.overjet.com/blog/overjet-named-to-linkedin-s-2023-top-startups-list-in-united-states
• Included on the definitive 2022 Forbes AI 50 https://www.prnewswire.com/news-releases/overjet-named-to-forbes-ai-50-list-of-most-promising-ai-companies-shaping-the-future-301544947.html

EEOC

Overjet is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. Even if you don't meet 100% of the qualifications for this job, we strongly encourage you to apply!

If you are a Colorado resident: Please contact us by emailing recruiting@overjet.ai to receive compensation and benefits information for this role. Please include the job title in the subject line of the email.