Vice President Regulatory Affairs Quality Assurance (Salt Lake City)

Vice President, Regulatory Affairs & Quality AssuranceUnited States - Salt Lake CityMedical Device & Biomaterials Sector$180,000 – $225,000 Base + Bonus + RSUsAn innovative and rapidly growing medical device and biomaterials company is seeking a Vice President of Regulatory Affairs & Quality Assurance to lead global regulatory strategy and quality operations across next-generation implantable technologies and advanced biomaterial platforms.This is a key executive leadership role within a highly specialised organisation focused on developing and commercialising cutting-edge implantable medical technologies, including additive manufacturing, patient-specific solutions, and advanced biomaterial applications.The successful candidate will play a critical role in driving regulatory approvals, strengthening quality systems, supporting commercial scale-up, and enabling future growth through strategic partnerships and licensing initiatives.The OpportunityYou will lead the global Regulatory Affairs and Quality Assurance function, overseeing regulatory submissions, compliance strategy, quality systems, manufacturing quality, and post-market activities across a portfolio of innovative medical technologies.This role requires a strategic yet hands-on leader who can operate effectively within a fast-paced, growth-stage environment while balancing innovation with regulatory and quality rigor.Key ResponsibilitiesRegulatory Affairs LeadershipDevelop and execute US and international regulatory strategies for:Implantable medical devicesAdditively manufactured and patient-specific technologiesBiomaterial-based platforms and applicationsWound management and soft tissue technologiesLead and manage FDA submissions including:510(k)De NovoIDEPMAQ-SubmissionsServe as the primary regulatory interface with FDA and international regulatory authoritiesAssess regulatory risks, timelines, and market access strategies for new products and design changesQuality Systems & ComplianceOwn and continuously improve the Quality Management System (QMS)Ensure compliance with:21 CFR Part 820ISO 13485ISO 14971Applicable ASTM and additive manufacturing standardsOversee:Design controlsProcess controlsSupplier qualityCAPAChange controlComplaint handlingInternal and external auditsSupport scalable manufacturing readiness and commercial growthProduct Launch & Lifecycle ManagementProvide regulatory and quality leadership for new product launches and lifecycle management activitiesSupport manufacturing scale-up, process validation, and risk mitigation initiativesOversee post-market surveillance and vigilance activitiesCollaborate cross-functionally with R&D, Manufacturing, Clinical, and Commercial teamsStrategic & Cross-Functional LeadershipAct as a key advisor to executive leadership on regulatory and quality mattersManage relationships with notified bodies, testing laboratories, consultants, and strategic partnersSupport licensing, co-development, and commercial partnership activitiesContribute to investor and board-level regulatory communicationsRequirementsRequired ExperienceBachelor's degree in Engineering, Life Sciences, or related discipline (Master's preferred)10+ years of progressive Regulatory Affairs and Quality experience within medical devices, orthopaedics, biomaterials, or related sectorsStrong FDA submission experience including:510(k)De NovoIDEPMADeep understanding of:FDA QSRISO 13485ISO 14971Medical device quality systemsExperience supporting manufacturing quality, supplier quality, and regulatory auditsHighly PreferredAdditive manufacturing / 3D-printed medical devicesPatient-specific or custom implant technologiesBiomaterials or materials-science-driven productsExperience with antimicrobial or antipathogenic technologiesDirect FDA interaction experience including Q-Subs and inspectionsLean Six Sigma certification and process improvement expertiseWhat's on Offer$180,000 – $225,000 base salaryBonus opportunityRSUs / equity participationOpportunity to shape the regulatory and quality strategy of a highly innovative medtech platform businessHigh-impact executive leadership role within a growth-stage organisation