Quality & Regulatory Manager — Surgical Navigation; San Diego, hybrid
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-09-18
Listing for:
Kato Medical Inc.
Full Time
position Listed on 2026-09-18
Job specializations:
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
We're Kato Medical, and we're building Fas Track™ — an AI-powered surgical navigation platform that turns standard fluoroscopy into precise 3D guidance. Our 510(k) is under FDA review, we're preparing for launch, and we're hiring our first dedicated Quality leader.
What you'll own:- The QMS end-to-end (ISO 13485 / FDA QMSR) as Management Representative
- Design control integrity, risk management (ISO 14971), and launch readiness
- Software lifecycle compliance (IEC 62304) for AI/ML-driven navigation software
- Regulatory ownership as you integrate — our contractor handles the active review; future submissions are yours
- Design transfer, supplier quality, and post-market readiness as we launch
- 5+ years in medical device quality, Class II / 510(k) experience
- Hands‑on QMS buildout at a startup or small company
- Working fluency in ISO 13485, ISO 14971, IEC 62304
- Bonus: navigation, robotics, or imaging background; familiarity with FDA AI/ML guidance
This is a ground-floor, player‑coach role with real ownership: you'll write the procedures, host the audits, and shape how a novel device gets to patients.
San Diego, CA (hybrid) | Salary + equity
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