RA & QA Specialist

Company DescriptionLVIS Corporation is on a mission to revolutionize the entire continuum of neurological care by developing AI driven software tools to help physicians accelerate patient throughput and improve patient diagnostic and treatment outcomes. We have an international team with our headquarters located in Palo Alto, California, USA, and we have an office in Gangnam, Seoul, South Korea. We are looking for talented individuals to join us in our mission to transform the neurology health care industry.Role OverviewThis is a combined RA (Regulatory Affairs) and QA (Quality Assurance) role with a QA emphasis, to immediately support DMPA/kGMP alignment and readiness for the US QMSR (ISO 13485-aligned) transitionResponsibilities QADocument Control (Dot Compliance) administration: document lifecycle, version/revision history, e-signature workflows, training assignments/recordsChange Control & CAPA: operate change control; root-cause analysis, CAPA planning, and effectiveness verificationSupplier Quality: maintain/approve ASL, issue/track SCARs, monitor supplier performance/risks, manage supplier change notificationsRisk Management (ISO 14971): hazard analysis, FMEA, and risk traceability documentation and updatesNon-product software validation (CSV): validation planning/testing/evidence for eQMS, issue trackers (e.g., JIRA), and cloud servicesSaMD QMS alignment: review against IEC 62304, review V&V plans/protocols, check the Requirements Traceability MatrixInternal Audit & Training: audit readiness/evidence organization; build SOPs/forms/checklists/training materials and deliver trainingIncorporate regulatory changes into the QMS: DMPA, kGMP, cybersecurity guidance (SOP revisions, training rollout) RANECA/HIRA & New Health Technology Evaluation deferment (NHTE) packages: collect and structure clinical-effectiveness and health-economic evidenceHospital/IRB coordination: prepare required documentation, manage submissions and timelines, support Q&AClinical protocol drafting support: align endpoints, statistics, and data collection/monitoring elementsRegulatory submissions support: draft MFDS Pre-Submission queries; prepare FDA 510(k) sections (format checks, reference collation)Regulatory intelligence: monitor and brief the team on updates to regulations, standards, and guidanceRequirementsMinimum Qualifications3+ years in medical devices in QA or RA (SaMD/AI preferred)Working knowledge of ISO 13485 and awareness of the US QMSR (ISO 13485-aligned) transition by 2026-02-02; hands-on ISO 14971 (hazard analysis, FMEA, risk traceability)Document Control (Dot Compliance) administration experience; understanding of change/training/e-signature workflowsExecuted Change Control & CAPA; Supplier Quality operations (ASL/SCAR)CSV experience for non-product software (eQMS/issue trackers/cloud)IEC 62304 basics; able to review V&V protocols and check traceabilityInternal audit preparation/participation; capable of building SOPs/checklists/training materialsPreferred QualificationsExperience with DMPA and kGMP; exposure to MFDS submissions/auditsExperience assembling NECA/HIRA / NHTE packagesHospital/IRB coordination and clinical protocol documentationDrafting or formatting FDA Pre-Sub/510(k) sectionsCertifications such as RAC, CQA, or experience delivering QA/RA trainingInterview ProcessPhone Screening > Online Interview (1 or 2 rounds) > Final Interview > Reference Check > Compensation Discussion > Final OfferBenefitsFlexible working hours (start between 7:30-9:00 AM)Public holidays and Labor Day offFlat, open, and casual cultureSnacks, coffee, and tea providedModern office with high-performance equipmentEarly leave on birthdays 🎂