Senior Manager Regulatory and Quality Affairs

Senior Manager Regulatory and Quality AffairsSenior Manager Regulatory and Quality AffairsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from MeditMedit 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 OpportunityThis 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 plusSeniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionQuality Assurance and Accounting/AuditingIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at Medit by 2xInferred from the description for this jobMedical insuranceVision insurance401(k)Paid maternity leavePaid paternity leaveGet notified when a new job is posted.Sign in to set job alerts for “Regulatory Manager” roles.Irvine, CA $160,000.00-$180,000.00 1 week agoIrvine, CA $100,000.00-$173,500.00 1 week agoSenior Director of Regulatory & Quality StrategyIrvine, CA $200,000.00-$260,000.00 5 days agoBrea, CA $125,000.00-$140,000.00 3 weeks agoState Licensing & Regulatory Compliance ManagerLake Forest, CA $120,000.00-$130,000.00 3 days agoLabelling Senior Project Manager (Medical Device & Regulatory Compliance) - FulltimeDirector of Quality and Regulatory AffairsSenior Contracts & Legal Specialist - Remote in the USIrvine, CA $208,000.00-$260,000.00 1 week agoNewport Beach, CA $137,500.00-$195,000.00 1 month agoRegulatory Affairs and Compliance Analyst (Medicare)Orange, CA $68,015.00-$108,824.00 3 days agoManager Accreditation & Regulatory Compliance : Quality Management - Full TimeIrvine, CA $123,000.00-$174,000.00 1 week agoIrvine, CA $125,000.00-$145,000.00 1 week agoSenior Director, BWI Quality & ComplianceIrvine, CA $173,000.00-$299,000.00 1 week agoClient Development Lead, Validation and Regulatory ComplianceIrvine, CA $160,000.00-$230,000.00 1 week agoIrvine, CA $190,000.00-$230,000.00 1 week agoUS/CAN Lawyer - Legal Contract and Compliance ManagerFullerton, CA $130,000.00-$140,000.00 3 months agoIrvine, CA $131,700.00-$223,900.00 2 weeks ago10393 – IT Governance, Risk & Compliance (GRC) ManagerFountain Valley, CA $112,830.00-$173,756.00 1 week agoIrvine, CA $79,000.00-$139,500.00 1 week agoIrvine, CA $112,000.00-$147,000.00 1 day agoGlobal Internal Audit & Compliance ManagerHYBRID - Global Internal Audit & Compliance Manager - SOX, CISHYBRID - Global Internal Audit & Compliance Manager - SOX, CISIrvine, CA $130,000.00-$160,000.00 3 days agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Created: 2025-10-06