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Medit · 2 months ago

Senior Manager, Regulatory & Quality Affairs

Newport Beach,CA,US

Full-time

Onsite

Senior Level

7+ years exp

Medit is a global leader in 3D dental imaging and digital dentistry, and they are seeking a senior-level RA/QA expert to own and lead their regional compliance strategy. This role involves managing regulatory and quality operations for both medical device hardware and software as a medical device across the U.S., Canada, and LATAM, including FDA submissions and ISO compliance.

3D TechnologyDentalHealth CareMedicalMedical Device

Responsibilities

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

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

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

Qualification

Regulatory AffairsQuality AssuranceFDA Class II 510(k)ISO 13485MDSAPQSRCross-border ExperienceEnglish FluencySpanishPortugueseProject ManagementDocumentation Skills