Head of Regulatory

Lead the Future of Dentistry.

Overjet is the worldleader in dental AI. Already thousands of dental providers and insurers rely on our platform to deliver the best possible care. Now were 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 theres 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 Overjets 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 Overjets regulatory and quality systems.
• Partner with Product Clinical Engineering and QA teams to ensure regulatory requirements are embedded throughout the product lifecycleincluding design controls validation verification and risk management.
• Oversee development and maintenance of submissionready documentation and regulatory dossiers.
• Provide regulatory input for clinical studies realworld 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 customerfacing 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)
  • Canadas 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 crossfunctional teams.
• High degree of ownership selfdirection and comfort working in fastpaced highgrowth environments.
• Bachelors degree in a scientific or engineering discipline required; advanced degree (e.g. MS PhD JD MPH) or RAC credential preferred.

Why Overjet

• Competitive Compensation and Equity
• Hybrid workplace that provides flexibility vibrant inperson workspaces and the ability to build strong connections across all of Overjet regardless of location
• 401k plans with a matching program
• Medical Dental and Vision coverage: 99% employee premium covered 75% dependent premium covered
• Life and ADD Insurance
• 8 weeks Paid Parental Leave
• Optional HSA with Employer contribution
• Flexible Time Off and company paid holidays
• Annual Learning and Development Stipend
• Work from Home Stipend

Our Hybrid Workplace

We have a unique hybrid workplace at Overjet which combines the teamwork of meeting in person with the flexibility of working from anywhere.

Many of our positions are based in San Mateo New York City Boston and Lahore. The Jetsetters who live in these geohubs come to the office on Tuesdays and Wednesdays while having the option to work from home the rest of the week.

Our People Team is happy to answer any questions about what hybrid work means for your specific role!

Overjets Values

• Excellence: We set ambitious goals and strive for excellence.
• Velocity: We focus act with urgency and deliver results.
• Ownership: We take ownership dive deep and solve problems.
• Winwin: We play to win setting ourselves and our customers up for success.
• Growth: We stay curious seek feedback and continuously learn and grow.

Company Recognition

• Named one of theTIME Best Inventions of 2024
• Recognized inNewsweeksMost Loved Workplaces in America 2024
• Won the Dental Health category at theDigital Health Awards 2024
• Honored as one of the2024 Best Places to Work by Built In
• Recognized as one of theTop Startups of 2023 by LinkedIn
• Named one of the2023 Worlds Most Innovative Companies byFast Company
• Included on the definitive2022 Forbes AI 50
• Featured inBloombergForbesFast Company andTechCrunch

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 dont 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 to receive compensation and benefits information for this role. Please include the job title in the subject line of the email.