Auf einen Blick
- Aufgaben: Übersetze regulatorische Anforderungen in klare Produktanforderungen und unterstütze die Entwicklung.
- Unternehmen: Innovatives MedTech-Unternehmen mit Fokus auf digitale Patientenüberwachung.
- Vorteile: Zentrale Rolle in einem dynamischen Umfeld mit enger Zusammenarbeit im Team.
- Weitere Informationen: Pragmatische, schnelllebige Umgebung mit echten Entwicklungsmöglichkeiten.
- Warum dieser Job: Gestalte die Zukunft der Patientenüberwachung und arbeite an bedeutenden Projekten.
- Qualifikationen: Erfahrung in der Regulierung von medizinischer Software und technischem Schreiben.
Das prognostizierte Gehalt liegt zwischen 60000 - 78000 € pro Jahr.
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 Med Tech 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, algorithms and devices.
- Verification and validation: drive V&V – planning, evidence collection and reporting.
- Technical documentation: write and maintain the technical documentation, including design history, risk files and V&V records.
- Process embedding: embed regulatory compliance into the development process and improve the process where it blocks the team rather than helping it.
- Audit readiness: support audit readiness for ongoing certifications and for new features (respiration, immobility monitoring, AI).
- Clinical evaluation support: support our clinical evaluation work for the software features (clinical evaluation planning and evidence) together with our research and clinical partners.
Qualifications
- Must‑haves
- Solid regulatory experience for medical software, with practical command of MDR, IEC 62304 and ISO 14971.
- Hands‑on experience with requirements engineering, traceability and verification and validation in a regulated software environment.
- Strong, clear technical writing: happy to produce design history, risk files and V&V records yourself.
- Ability to work shoulder to shoulder with software, algorithm and device engineers and to embed compliance into how they actually develop.
- Structured, pragmatic and self‑driven.
- Preferred skills
- Experience with Software as a Medical Device and cloud‑hosted / Saa S‑delivered medical products.
- Exposure to Class I and to the move toward Class IIa software, and to taking new regulated software functions through development to market.
- Experience supporting clinical evaluations and study evidence for software features.
- Familiarity with the Swiss and EU landscape (Swissmedic, EU markets).
- Comfort with modern, AI‑assisted documentation and tooling.
Benefits
- A central, hands‑on role at the point where regulation meets real product development.
- Close collaboration with our software, algorithm and device teams, the CTPO and the PRRC.
- A meaningful product and a company that wants to do regulation the serious way.
- A pragmatic, fast‑moving Swiss Med Tech environment.
About us
QUMEA is a pioneer in digital patient mobility monitoring and is setting new standards in patient safety.
Our radar‑based system captures movements in patient rooms completely contactlessly and anonymously, supporting healthcare professionals in real time whenever patients need assistance.
The result: greater safety for patients, noticeable relief for nursing staff, and clear clinical added value.
Application
To apply, submit your CV and relevant supporting documents.
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Technical Product & Regulatory Manager (Medical Software / MDR) (m/f/d) Arbeitgeber: QUMEA
QUMEA ist ein hervorragender Arbeitgeber, der eine innovative und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten im Bereich Regulierung und Qualität weiterentwickeln können. Mit einem starken Fokus auf Teamarbeit und interdisziplinäre Zusammenarbeit fördern wir das Wachstum unserer Mitarbeiter und bieten zahlreiche Weiterbildungsmöglichkeiten. Unsere zentrale Lage ermöglicht es Ihnen, in einem dynamischen Umfeld zu arbeiten, das von modernster Technologie und einem klaren Engagement für Qualität geprägt ist.
