Head of Regulatory

Overjet
San Mateo
Workplace: HybridFull timeFunction: Quality & Regulatory (Non-Software)Education: bachelorsSkills: ["Communication","Ownership","Self-direction"]

Own the global regulatory function for a healthtech AI platform, building and scaling processes as the company grows. Lead regulatory strategy and manage submissions across FDA, Health Canada, EU MDR, UK MHRA, and Australia TGA. Serve as the main interface with regulatory authorities and Notified Bodies, embed requirements across the product lifecycle, and guide inspections, audits, and submission-ready documentation.

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FursaFursa
Overjet
Overjet
2 days ago

Head of Regulatory

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Source: Company careers pageValidated by: Fursa AI
Last checked: 8 hours agoStatus: Live

Job Summary

Own the global regulatory function for a healthtech AI platform, building and scaling processes as the company grows. Lead regulatory strategy and manage submissions across FDA, Health Canada, EU MDR, UK MHRA, and Australia TGA. Serve as the main interface with regulatory authorities and Notified Bodies, embed requirements across the product lifecycle, and guide inspections, audits, and submission-ready documentation.
Location: San Mateo
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Director level

Key Responsibilities

  • •Develop, lead, and execute the global regulatory strategy, aligning with business goals and evolving international requirements.
  • •Own regulatory planning, coordination, and submission activities, including FDA 510(k), De Novo, Health Canada MDL, EU MDR, UK MHRA registration, and Australian TGA processes.
  • •Act as the primary point of contact with regulatory authorities and Notified Bodies for product approvals, QMS compliance, and ongoing reporting.
  • •Interpret and communicate regulatory changes across internal stakeholders and ensure requirements are embedded across the product lifecycle (design controls, validation, verification, risk management).
  • •Lead regulatory documentation and dossiers, provide input for clinical studies and real-world evidence/data usage, and manage inspections, audits, and team scaling.

Pay and Benefits

Perks:401kHealth InsuranceDentalVisionPaid LeaveLife InsuranceLearning BudgetHsa

Key Requirements

  • •7+ years of regulatory affairs experience for medical devices, including 2+ years for software as a medical device (SaMD) under FDA and at least one international framework.
  • •Proven success managing regulatory submissions and approvals across multiple jurisdictions, including FDA 510(k), De Novo, and CE Marking (plus relevant device frameworks).
  • •Deep knowledge of global regulatory requirements, including U.S. FDA (21 CFR Part 820 and SaMD guidance), EU MDR/IVDR (Notified Body processes), UK MHRA, Health Canada, and Australian TGA.
  • •Strong familiarity with ISO 13485, ISO 14971, and IEC 62304; experience with ISO 27001 and data protection standards (HIPAA, GDPR) is a plus.
  • •Bachelor’s degree in a scientific or engineering discipline; advanced degree (e.g., MS, PhD, JD, MPH) or RAC credential preferred.
Experience:Medical devicesSaMDHealthtech
Education:Bachelor's
Skills:CommunicationOwnershipSelf-direction
Certifications:RAC
Tech Stack:FDA 510(k)De Novo21 CFR Part 820SaMDHealth Canada Medical Device License (MDL)EU MDREU Notified BodiesUK MHRA registrationAustralian TGAISO 13485ISO 14971IEC 62304ISO 27001HIPAAGDPRQMSCE MarkingIVDRMHRATGA

Company Brief

Overjet
Overjet builds FDA-cleared AI for dental imaging that helps dentists, payers, and dental organizations detect pathologies, standardize diagnoses, automate claims review, and improve patient care using clinically validated radiographic AI.
Industry: HealthTech
Company Size: Medium (51 to 250 employees)
Growth: Scaleup
Valuation: USD 500M to 1B
Funding: Series C
Headquarters: Boston, United States
Founded: 2018
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