Company Description
LVIS 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 Overview
- This 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) transition.
Responsibilities
1) QA
- Document Control (Dot Compliance) administration: document lifecycle, version/revision history, e-signature workflows, training assignments/records
- Change Control & CAPA: operate change control; root-cause analysis, CAPA planning, and effectiveness verification
- Supplier Quality: maintain/approve ASL, issue/track SCARs, monitor supplier performance/risks, manage supplier change notifications
- Risk Management (ISO 14971): hazard analysis, FMEA, and risk traceability documentation and updates
- Non-product software validation (CSV): validation planning/testing/evidence for eQMS, issue trackers (e.g., JIRA), and cloud services
- SaMD QMS alignment: review against IEC 62304, review V&V plans/protocols, check the Requirements Traceability Matrix
- Internal Audit & Training: audit readiness/evidence organization; build SOPs/forms/checklists/training materials and deliver training
- Incorporate regulatory changes into the QMS: DMPA, kGMP, cybersecurity guidance (SOP revisions, training rollout)
2) RA
- NECA/HIRA & New Health Technology Evaluation deferment (NHTE) packages: collect and structure clinical-effectiveness and health-economic evidence
- Hospital/IRB coordination: prepare required documentation, manage submissions and timelines, support Q&A
- Clinical protocol drafting support: align endpoints, statistics, and data collection/monitoring elements
- Regulatory 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 guidance
Requirements
Minimum Qualifications
- 3+ 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 workflows
- Executed 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 traceability
- Internal audit preparation/participation; capable of building SOPs/checklists/training materials
Preferred Qualifications
- Experience with DMPA and kGMP; exposure to MFDS submissions/audits
- Experience assembling NECA/HIRA / NHTE packages
- Hospital/IRB coordination and clinical protocol documentation
- Drafting or formatting FDA Pre-Sub/510(k) sections
- Certifications such as RAC, CQA, or experience delivering QA/RA training
Interview Process
- Phone Screening > Online Interview (1 or 2 rounds) > Final Interview > Reference Check > Compensation Discussion > Final Offer
Benefits
- Flexible working hours (start between 7:30–9:00 AM)
- Public holidays and Labor Day off
- Flat, open, and casual culture
- Snacks, coffee, and tea provided
- Modern office with high-performance equipment
- Early leave on birthdays 🎂
