Head of Regulatory

 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.