People First, in practice.
Every project decision — scope, sequence, escalation — is filtered through the patient, the clinician, and your own bandwidth. Burnout is a process failure, not a badge.
Build a MedTech career where speed serves patients.
We hire people who want their work to move the needle for patients — not bill hours against it.
Lean removes the dead weight.
We instrument workflows so the predictable parts stay automated and your attention goes to judgment, strategy, and relationships. No timesheet padding, no manufactured complexity.
Korea-rooted, globally scoped.
Seoul HQ orchestrates MFDS, KGMP, and KLH work; the network spans 24+ countries. Careers here scale across jurisdictions without changing employer.
The kinds of people we hire.
We do not have a fixed org chart. We have problems to solve and a Lean operating model to defend. If your specialty makes the device get to patients faster, we want to hear from you.
Regulatory
Regulatory Affairs
Lead the MFDS, FDA, and EU MDR submissions that bring devices to market. Strategy, dossier authoring, deficiency defense.
Korean MFDS pathway strategyFDA 510(k) / De Novo / PMAEU MDR / IVDR technical documentation
Quality
Quality & KGMP
Build and defend the QMS systems that make compliance the path of least resistance for our clients and their manufacturing sites.
ISO 13485 / KGMP implementationAudit readiness & inspection defenseCAPA, NC, and supplier programs
Clinical
Clinical & Reimbursement
Run Korean clinical investigations, NECA evaluations, and HIRA reimbursement dossiers so devices reach not just approval but adoption.
MFDS clinical trial INDNECA new health-technology assessmentHIRA reimbursement strategy
Engineering
Software & Product
Engineer the EQMS, PLM, MES, and RIM products that make Lean operations real. TypeScript / React / Node / cloud-native.
Full-stack TypeScript engineering21 CFR Part 11 / Annex 11 compliant featuresAI/ML for regulatory intelligence
Operations
Operations & Client Success
Hold the through-line on long-arc engagements — KGMP, KLH, post-market — so clients and the team stay aligned without friction.
Project orchestration across jurisdictionsClient success for retainer programsVendor & partner network management
What it’s like to work here.
Three commitments we keep — to clients and to each other.
Ownership without theatre.
You hold real scope from day one. We do not run engagements through five layers of approval; we run them through the person closest to the problem.
Learning compounds, monthly.
Regulations move every quarter. We invest in study time, certifications, and conference attendance because the alternative is decay.
Transparent everything.
Compensation bands, project profitability, client feedback — open by default. The same Lean discipline we apply to client work, we apply to ourselves.