Head of Regulatory (AI)

Location: Hybrid role based in San Mateo, California, with office attendance on Tuesdays and Wednesdays for employees in U.S. geo-hubs. Other listed geo-hubs include New York City, Boston, and Salt Lake City; remote work is available from home on the remaining days.

Company

hirify.global develops AI technology for dental providers and insurers to improve oral healthcare.

What you will do

• Develop and execute the global regulatory strategy in alignment with business goals and international requirements.
• Plan, coordinate, and submit regulatory filings, including FDA 510(k), De Novo, Health Canada MDL, EU MDR, UK MHRA, and Australian TGA submissions.
• Act as the primary contact for regulatory authorities and notified bodies regarding approvals, QMS compliance, audits, inspections, and ongoing reporting.
• Partner with Product, Clinical, Engineering, and QA teams to embed regulatory requirements into design controls, validation, verification, risk management, and the product lifecycle.
• Provide regulatory input for clinical studies, real-world evidence programs, data usage, privacy, cybersecurity, and AI risk management.
• Build and manage the regulatory team as the company scales globally.

Requirements

• 7+ years of regulatory affairs experience in medical devices, including 2+ years working with software as a medical device under FDA and at least one international framework.
• Proven experience managing submissions and approvals across multiple jurisdictions, including FDA 510(k), De Novo, CE Marking, MDEL, UK MHRA registration, and TGA conformity assessments.
• Deep knowledge of U.S. FDA, Canadian, EU MDR/IVDR, UK, and Australian TGA regulatory frameworks.
• Experience working directly with agencies and notified bodies, leading meetings, and responding to questions or deficiencies.
• Expertise in ISO 13485, ISO 14971, IEC 62304, quality management systems, compliance audits, and inspection readiness.
• Bachelor’s degree in a scientific or engineering discipline required.

Nice to have

• Advanced degree such as MS, PhD, JD, or MPH.
• RAC credential.
• Familiarity with ISO 27001, HIPAA, and GDPR.

Culture & Benefits

• Hybrid workplace combining in-person collaboration with work-from-home flexibility.
• 401(k) plan with matching contributions.
• Medical, dental, and vision coverage with substantial employee premium coverage.
• Life and AD&D insurance, eight weeks of paid parental leave, flexible time off, and company-paid holidays.
• Optional HSA with employer contribution and an annual learning and development stipend.
• Values focused on excellence, velocity, ownership, and win-win collaboration.