Latest AI JobsBrowse Jobs
Overjet logo

Head of Regulatory

OverjetSan Mateo, CAR&D
Apply on company site
Salary
Not listed
Job type
Full-time
Work mode
Remote
Posted
11 Aug 2026
Status
Open · checked 7d ago

About this role

Overjet is seeking a Head of Regulatory to direct its core regulatory division in San Mateo, California, with remote flexibility available. This leadership position is tailored for an experienced professional eager to shape the future of dental technology by guiding international compliance operations.

Role Overview

The Head of Regulatory takes complete ownership of the global regulatory function at a rapidly scaling healthtech artificial intelligence enterprise. This individual leads the creation and execution of international regulatory strategies while scaling a high-performing team. Responsibilities include serving as the primary liaison with global health authorities and integrating regulatory controls deeply into software and clinical product lifecycles.

Key Responsibilities

Formulate and execute comprehensive global regulatory strategies aligned with long-term company goals.
Direct the planning and submission of critical regulatory filings, such as FDA 510(k), De Novo, Health Canada MDL, EU MDR, UK MHRA registration, and Australian TGA assessments.
Act as the central point of contact for regulatory agencies, Notified Bodies, and external quality auditors.
Partner closely with Product, Clinical, Engineering, and QA departments to embed regulatory requirements into verification, validation, and risk management.
Manage the creation and upkeep of robust submission-ready documentation and regulatory dossiers.
Provide expert regulatory guidance for clinical trials, data strategies, and real-world evidence initiatives.
Coordinate with compliance, machine learning, and security leaders to align with privacy, cybersecurity, and AI risk frameworks.
Lead external audits and inspections from regulatory bodies, ensuring quick remediation of any findings.
Hire, build, and oversee the global regulatory team as the company expands.

Requirements

Minimum of 7 years of professional experience in medical device regulatory affairs.
At least 2 years of direct experience handling Software as a Medical Device (SaMD) regulated by the FDA alongside an international framework.
Proven track record of managing multi-jurisdictional regulatory submissions and approvals like 510(k), De Novo, and CE marking.
In-depth understanding of worldwide standards including U.S. FDA 21 CFR Part 820, Canada Medical Devices Regulations, EU MDR/IVDR, UK regulations, and Australian TGA.
Direct experience leading interactions, meetings, and deficiency responses with regulatory agencies and notified bodies.
Expert knowledge of ISO 13485, ISO 14971, and IEC 62304 standards.
Bachelor’s degree in an engineering or scientific discipline.

Nice to Have

Advanced degrees such as an MS, PhD, JD, or MPH.
Regulatory Affairs Certification (RAC).
Familiarity with ISO 27001 and data protection regulations like HIPAA and GDPR.

Skills and Tools

Global regulatory strategy and execution
SaMD and AI risk management frameworks
Quality Management Systems (QMS) and audit readiness
Cross-functional communication and leadership

Salary and Benefits

Competitive salary paired with equity opportunities
Flexible hybrid workplace model with vibrant local workspaces
401(k) retirement plan featuring a matching program
Comprehensive medical, dental, and vision insurance with 99% of employee premiums covered
Life and AD+D insurance protection
8 weeks of paid parental leave
Optional Health Savings Account (HSA) containing employer contributions
Flexible time off policy accompanied by company-paid holidays
Annual stipend dedicated to learning and development

About the Company

Overjet stands as a global leader in dental artificial intelligence, empowering thousands of providers and insurers to deliver exceptional care. Recognized broadly across innovation lists—including Fast Company's Most Innovative Companies and TIME Best Inventions—the organization fosters a culture built on excellence, velocity, ownership, and win-win collaboration.

How to Apply

Interested candidates should visit the official Overjet careers page to submit an application for this position.

Questions candidates ask

Where is this job located?

This position is based out of San Mateo, California, with remote work flexibility available as part of a hybrid workplace model.

What level of experience is required?

Candidates must have at least 7 years of experience in regulatory affairs for medical devices, including a minimum of 2 years focused specifically on Software as a Medical Device (SaMD).

What educational background is needed?

A Bachelor's degree in a scientific or engineering field is required. Advanced degrees and a RAC credential are preferred.

What regulatory frameworks are relevant to this role?

The role requires familiarity with the U.S. FDA, Health Canada Medical Devices Regulations, EU MDR and IVDR, UK Medical Device Regulations, and the Australian TGA.

What perks and insurance benefits are offered?

Benefits include competitive compensation, equity, a 401(k) match, robust medical/dental/vision coverage with 99% of employee premiums paid, life insurance, 8 weeks of paid parental leave, flexible time off, and a learning stipend.

Ready to apply?

The application is on the official Overjet careers page.

Apply on company site