Senior Manager, Regulatory

2 weeks ago

Newport Beach, California, United States Medit USA Inc Full time $150,000 - $250,000 per year
:

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 role covers both medical device hardware and Class II SaMD (software as a medical device). You will take full ownership of regulatory and quality operations across the U.S., Canada, and LATAM — including FDA Class II 510(k) submissions, ISO 13485 quality systems, and regulatory leadership for both physical devices and software platforms. You'll collaborate directly with our global HQ in Korea and operate with a high degree of autonomy.

What You'll Own

Regulatory Strategy & Submissions

  • Lead and manage Class II regulatory submissions including FDA 510(k), Health Canada, ANVISA, and LATAM filings for both hardware and software
  • Serve as U.S. and LATAM regulatory liaison with global HQ and local authorities
  • Monitor evolving regulations and proactively adjust strategy across jurisdictions

Quality System Ownership

  • Ensure ongoing compliance with ISO 13485, MDSAP, and QSR requirements
  • Own and maintain quality assurance systems, CAPAs, SOPs, and change control
  • Support audits and inspections from FDA, Health Canada, and other regulators

Cross-Functional Leadership

  • Work closely with R&D, product, legal, and support teams to ensure regulatory alignment
  • Guide internal teams on regulatory best practices and QA processes
  • Represent Medit in external conversations with regulatory bodies and partners

Requirements:

What We're Looking For

  • 7–10+ years of experience in Regulatory Affairs and Quality Assurance, ideally with both medical devices and digital health products
  • Demonstrated success leading FDA Class II 510(k) submissions, especially for SaMD
  • Strong knowledge of ISO 13485, MDSAP, QSR, and related standards
  • Experience operating independently in cross-border environments (U.S., Canada, LATAM)
  • Proven ability to make decisions and drive compliance without heavy oversight
  • Excellent project management and documentation skills
  • Bachelor's degree required; advanced degree or RAC certification a plus
  • English fluency required; Spanish or Portuguese is a plus

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