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Head of Regulatory

Head of Regulatory to lead global regulatory strategy at Overjet.
Overjet
Remote
Hybrid
On-Site
United States
Undisclosed salary
Job Description
Overjet is seeking a Head of Regulatory to lead its regulatory function. This role is crucial for a growing Healthtech AI company focused on dental AI solutions. The Head of Regulatory will report to the VP of Machine Learning & Compliance and will be a key member of the Engineering team. The primary responsibility is to develop and execute Overjet’s global regulatory strategy, ensuring alignment with business goals and evolving international requirements.

Role involves:
  • Planning, coordinating, and submitting regulatory filings.
  • Serving as the primary point of contact with regulatory authorities.
  • Interpreting and communicating new regulatory requirements.
  • Partnering with Product, Clinical, Engineering, and QA teams.
  • Overseeing development and maintenance of submission-ready documentation.
  • Providing regulatory input for clinical studies and data usage strategies.
  • Collaborating with the VP of Machine Learning & Compliance and Director of Security.
  • Supporting regulatory due diligence for partnerships, audits, and customer-facing compliance engagements.
  • Leading inspections and audits from regulatory authorities.
  • Building and managing the regulatory team.

Requirements:
  • 7+ years of experience in regulatory affairs for medical devices, including 2+ years with software as a medical device (SaMD) under FDA.
  • Proven success managing regulatory submissions and approvals in multiple jurisdictions.
  • Deep knowledge of global regulatory frameworks.
  • Experience interacting directly with agencies and notified bodies.
  • 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.
  • Excellent communication skills.
  • 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; advanced degree preferred.

Overjet offers:
  • Competitive Compensation and Equity
  • Hybrid workplace that provides flexibility
  • 401k plans with a matching program
  • Medical, Dental and Vision coverage
  • 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
  • Work from Home Stipend
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