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Overjet is seeking a Head of Regulatory to lead and build the regulatory function at a fast-growing dental AI healthtech company. This role owns the global regulatory strategy and execution across multiple jurisdictions including the FDA, Health Canada, EU MDR, UK MHRA, and Australian TGA.
Key responsibilities include developing and executing Overjet's global regulatory strategy aligned with business goals; planning and coordinating regulatory submissions (FDA 510(k), De Novo, Health Canada MDL, EU MDR, UK MHRA, TGA); serving as primary contact with regulatory authorities for product approvals and QMS compliance; interpreting and communicating evolving global regulatory requirements to internal stakeholders; partnering with Product, Clinical, Engineering, and QA teams to embed regulatory requirements throughout the product lifecycle; managing submission-ready documentation and regulatory dossiers; providing regulatory input for clinical studies and real-world evidence programs; collaborating with VP of ML & Compliance and Director of Security on privacy, cybersecurity, and AI risk management alignment; supporting regulatory due diligence for partnerships and audits; leading inspections and audits from regulatory authorities; and building and managing the regulatory team as the company scales globally.
Required qualifications include 7+ years in medical device regulatory affairs with 2+ years in software as a medical device (SaMD) under FDA and experience with at least one international framework (Health Canada, EU MDR, MHRA, TGA). Proven success managing multi-jurisdictional submissions (510(k), De Novo, CE Marking, MDEL, UK MHRA, TGA). Deep knowledge of FDA 21 CFR Part 820, SaMD guidance, Canada Medical Devices Regulations, EU MDR/IVDR, UK Medical Device Regulations, and Australian TGA. Direct experience with agencies and notified bodies. Expertise in ISO 13485, ISO 14971, IEC 62304; familiarity with ISO 27001, HIPAA, GDPR preferred. Strong QMS and compliance audit knowledge. Excellent cross-functional communication skills. Bachelor's in scientific or engineering discipline required; advanced degree (MS, PhD, JD, MPH) or RAC credential preferred.
Overjet is a venture-backed dental AI platform trusted by thousands of dental providers and insurers. The company offers competitive compensation and equity, hybrid work (Tuesdays/Wednesdays in-office in San Mateo with flexibility other days), 401(k) matching, comprehensive health coverage (99% employee premiums covered), 8 weeks paid parental leave, flexible PTO, and annual L&D stipend. Overjet has been recognized as #3 Best Place to Work in the US, #1 in NYC and San Francisco, #4 on FastCompany's Most Innovative Companies in Healthcare, and named a TIME Best Invention of 2024.
