Technical Product & Regulatory Manager (Medical Software / MDR) (m/f/d)

Full-time Management & Operations, Ingenieurwesen und Technik

Overview

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 Switzerland, the Nordics and the wider EU, and a subsidiary in Stockholm. New flagship use cases (respiration and immobility monitoring) and AI features are expanding our regulatory surface significantly, and we have no in‑house regulatory expert embedded in product development. That is the gap you fill.

Responsibilities

• Requirements translation: translate MDR (EU 2017/745), IEC 62304 and ISO 14971 into clear product and engineering requirements.
• Requirements engineering and traceability: own requirements engineering, traceability and risk‑related requirements across software, algorit...