Overjet

Overjet

Head of Regulatory

San Mateo, CA · Senior

Sponsorship not specifiedDetected 72 days ago
RESTMachine LearningComplianceProduct ManagementHIPAAClinical TrialsFDA RegulatoryMedical DevicesCommunicationRegulatory Affairs

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

3 transfer filings in the last year, covering 3 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • 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, ensuring alignment with business goals and evolving international requirements.
  • 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.
  • 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.
  • Lead the Future of Dentistry.
  • Overjet is looking for a Head of Regulatory to own the critical regulatory function at a growing Healthtech AI company.

Requirements

  • 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:
  • Experience interacting directly with agencies and notified bodies, including leading meetings and responses to questions or deficiencies.
  • 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.
  • 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).
  • 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)

Nice to have

  • Expertise in ISO 13485, ISO 14971, and IEC 62304
  • familiarity with ISO 27001 and data protection standards (HIPAA, GDPR) a plus.
  • Bachelor's degree in a scientific or engineering discipline required
  • advanced degree (e.g., MS, PhD, JD, MPH) or RAC credential preferred.

Compensation

  • Competitive Compensation and Equity

Benefits

  • Overjet is the world-leader in dental AI.
  • Already, thousands of dental providers and insurers rely on our platform to deliver the best possible care.
  • improve oral health for all.
  • 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.
  • Collaborate with the VP of Machine Learning & Compliance and Director of Security to align regulatory strategies with privacy, cybersecurity, and AI risk management frameworks.

Company info

  • Now, we're looking for talented people to fulfill our mission: improve oral health for all.
  • Now, we're looking for talented people to fulfill our mission:

Visa & Work Authorization

  • ice 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)
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This listing is sourced directly from Overjet's careers page and normalized into a canonical job model.