Senior Manager Regulatory and Quality Affairs (Newport Beach)

Medit is a global leader in 3D dental imaging and digital dentistry, with a $2B valuation and customers in over 100 countries. Our industry-leading intraoral scanners and open-platform software are transforming dental workflows worldwide. As we continue to grow across North and Latin America, we are seeking a senior-level RA / QA expert to own and lead our regional compliance strategy.

The Opportunity

This is a rare opportunity to take full ownership of regulatory and quality operations across the U.S., Canada, and LATAM. Youll serve as the point person for all RA / QA needs in the region, including FDA, Health Canada, and LATAM compliance, while collaborating with our HQ team in Korea. The ideal candidate will be confident operating independently, making strategic decisions, and guiding Medits compliance framework across diverse regulatory environments.

What Youll Own

Regulatory Strategy & Submissions

• Lead and manage Class II SaMD regulatory submissions (FDA 510(k), Health Canada, ANVISA, etc.)
• Monitor evolving regulations in all relevant countries and proactively adjust compliance strategies
• Serve as the U.S. and LATAM regulatory liaison with global HQ and local authorities

Quality System Ownership

Cross-Functional Leadership

What Were Looking For