Head of Regulatory

The role

The Head of Regulatory will own the regulatory function and lead global regulatory strategy. This person will manage regulatory filings, interact with authorities, and partner with internal teams to embed requirements into the product lifecycle.

What you will do

• Develop, lead, and execute Overjet’s global regulatory strategy.
• Own the planning, coordination, and submission of regulatory filings.
• Serve as the primary point of contact with regulatory authorities.
• Interpret and communicate new or evolving global regulatory requirements.
• Partner with Product, Clinical, Engineering, and QA teams.
• Manage development and maintenance of submission-ready documentation and regulatory dossiers.
• Provide regulatory input for clinical studies, real-world evidence programs, and data usage strategies.
• Collaborate with the VP of Machine Learning & Compliance and Director of Security.
• Support regulatory due diligence for partnerships, audits, and customer-facing compliance engagements.
• Lead inspections and audits from regulatory authorities and Notified Bodies.

Required qualifications

• 7+ years of experience in regulatory affairs for medical devices
• 2+ years with software as a medical device (SaMD) under FDA
• Experience with at least one international regulatory framework (e.g., Health Canada, EU MDR, MHRA, TGA)
• Proven success managing regulatory submissions and approvals in multiple jurisdictions
• Deep knowledge of U.S. FDA (21 CFR Part 820, SaMD guidance)
• Deep knowledge of Canada’s Medical Devices Regulations
• Deep knowledge of EU MDR and IVDR
• Deep knowledge of UK Medical Device Regulations
• Deep knowledge of Australian TGA
• Experience interacting directly with agencies and notified bodies
• Expertise in ISO 13485, ISO 14971, and IEC 62304
• Strong knowledge of quality management systems and compliance audits

Nice to have

• Familiarity with ISO 27001 and data protection standards (HIPAA, GDPR)
• Advanced degree (e.g., MS, PhD, JD, MPH)
• RAC credential

Benefits

• Competitive Compensation and Equity
• 401k plans with a matching program
• Medical, Dental and Vision coverage: 99% employee premium covered, 75% dependent premium covered
• 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

About the company

Overjet is the world-leader in dental AI. The company aims to improve oral health for all through new products, partnerships, and AI technology.