Senior Regulatory & Quality Lead / PRRC (MDR / ISO 13485) (m/f/d)
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QUMEA
📍 solothurn, solothurn, Switzerland
Job Description
QUMEA builds radar‑based, contactless patient monitoring. Our RADIQ sensor platform watches over patients without cameras and without anything worn on the body, giving care teams in hospitals and long‑term care reliable information on mobility, immobility and, increasingly, vital signs. We are a Swiss MedTech company with a growing presence across DACH, the Nordics and the wider EU, and a subsidiary in Stockholm. We treat regulatory as a deliberate strength, not an obstacle. We already have CE‑marked medical device functionality in the market, with more regulated features on the way. Your role You will own MDR at QUMEA end‑to‑end, act as our Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15, build and run our ISO 13485 quality management system, connect it with information security (ISO 27001) and risk management, and, above all, make compliance actually happen across the whole company. Why this role matters We are building this deliberately and at pace. Our qual...