Senior Manager Regulatory and Quality Affairs

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 OwnRegulatory Strategy & SubmissionsLead 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 strategiesServe as the U.S. and LATAM regulatory liaison with global HQ and local authoritiesQuality System OwnershipEnsure ISO 13485 and MDSAP compliance across the AmericasOversee quality assurance processes including CAPA, change control, audits, and SOPsSupport internal and external audits, including FDA and Health Canada inspectionsCross-Functional LeadershipCollaborate with R&D, product, legal, customer support, and HQ teams to ensure regulatory alignmentEducate and advise internal stakeholders on regulatory and quality requirementsRepresent Medit in external conversations with notified bodies, regulators, and partnersWhat We're Looking For7-10+ years of experience in regulatory affairs and quality assurance, ideally within medical devices or digital healthExperience with Class II SaMD and FDA 510(k) submissions is requiredDeep understanding of ISO 13485, QSR, MDSAP, and related global standardsExperience working across multiple markets including U.S., Canada, and/or LATAMProven ability to work independently, make sound decisions, and drive compliance autonomouslyStrong project management, documentation, and communication skillsBachelor's degree required; advanced degree or RAC certification a plusEnglish fluency required; Spanish or Portuguese a plus

Created: 2025-10-02