Head of Regulatory

Overjet • San Mateo, CA

3d • Hybrid

About The Position

Overjet is seeking a Head of Regulatory to lead its critical regulatory function within a rapidly growing Healthtech AI company. This role is a key part of the Engineering team, reporting to the VP of Machine Learning & Compliance. The position offers a significant opportunity to shape the future of dental care by building and managing the regulatory function as the company scales globally. The company emphasizes a culture of innovation and growth, providing a platform for individuals to accelerate their careers.

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, 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 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 Haves

• Advanced degree (e.g., MS, PhD, JD, MPH) or RAC credential preferred.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior