Head of Regulatory

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; Own the planning, coordination, and submission of regulatory filings, including FDA 510(k), De Novo, Health Canada Medical Device License (MDL), EU MDR, UK MHRA registration, and Australian TGA; Serve as the primary point of contact with regulatory authorities for product approvals, QMS compliance, and ongoing reporting; Interpret and communicate new or evolving global regulatory requirements across internal stakeholders; Partner with Product, Clinical, Engineering, and QA teams to ensure regulatory requirements are embedded throughout the product lifecycle; 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; Build and manage the regulatory team as Overjet scales globally

Requirements

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, and 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; 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 discipline required

Nice to have

Familiarity with ISO 27001 and data protection standards (HIPAA, GDPR); Advanced degree (e.g., MS, PhD, JD, MPH) or RAC credential preferred

Benefits

Competitive Compensation and Equity; Hybrid workplace that provides flexibility, vibrant in-person 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 AD+D Insurance; 8 weeks Paid Parental Leave; Optional HSA with Employer contribution; Flexible Time Off and company paid holidays; Annual Learning and Development Stipend