Senior Manager Regulatory and Quality Affairs

Job Description 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. You’ll 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 Medit’s compliance framework across diverse regulatory environments. What You’ll 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 Ensure ISO 13485 and MDSAP compliance across the Americas Oversee quality assurance processes including CAPA, change control, audits, and SOPs Support internal and external audits, including FDA and Health Canada inspections Cross-Functional Leadership Collaborate with R&D, product, legal, customer support, and HQ teams to ensure regulatory alignment Educate and advise internal stakeholders on regulatory and quality requirements Represent Medit in external conversations with notified bodies, regulators, and partners What We’re Looking For 7–10+ years of experience in regulatory affairs and quality assurance, ideally within medical devices or digital health Experience with Class II SaMD and FDA 510(k) submissions is

required Deep understanding of ISO 13485, QSR, MDSAP, and related global standards Experience working across multiple markets including U.S., Canada, and/or LATAM Proven ability to work independently, make sound decisions, and drive compliance autonomously Strong project management, documentation, and communication skills Bachelor's degree required; advanced degree or RAC certification a plus English fluency required; Spanish or Portuguese a plus

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