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

QUMEA AG
Solothurn, SO

Postuler rapidement

Détails de l'emploi

Temps partiel | 100%

Description complète du poste

Deine Mission

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.

The role in one sentence
Embedded in R&D, you are the regulatory counterpart to our software, algorithm and device teams: you turn medical device requirements into concrete engineering work, own the technical documentation, and drive verification and validation.

Deine Aufgaben im Detail

Requirements translation. You translate MDR (EU 2017/745), IEC 62304 and ISO 14971 into clear product and engineering requirements.
Requirements engineering and traceability. You own requirements engineering, traceability and risk-related requirements across software, algorithms and devices.
Verification and validation. You drive V&V: planning, evidence collection and reporting.
Technical documentation. You write and maintain the technical documentation, including design history, risk files and V&V records.
Process embedding. You embed regulatory compliance into the development process and improve the process where it blocks the team rather than helping it.
Audit readiness. You support audit readiness for ongoing certifications and for new features (respiration, immobility monitoring, AI).
Clinical evaluation support. You support our clinical evaluation work for the software features (clinical evaluation planning and evidence) together with our research and clinical partners.

Was du mitbringst

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: you are 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.

Strongly preferred

Experience with Software as a Medical Device and cloud-hosted / SaaS-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.

Warum QUMEA?

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 regulatory the serious way.
A pragmatic, fast-moving Swiss MedTech environment.

Bewerbung

If this sounds like your dream job, we'd love to hear from you! Apply now with your CV and relevant supporting documents.

Über uns

QUMEA ist Vorreiter im digitalen Patienten-Mobilitäts-Monitoring und setzt neue Standards in der Patientensicherheit. Unser radarbasiertes System erfasst Bewegungen im Patientenzimmer vollständig kontaktlos und anonym und unterstützt Pflegefachkräfte in Echtzeit, wenn Patient:innen Hilfe benötigen. Das Ergebnis: mehr Sicherheit für Patient:innen, spürbare Entlastung für das Pflegepersonal und ein klarer klinischer Mehrwert.

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Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : cloud engineer (luterbach so)

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Deine Mission

Deine Aufgaben im Detail

Was du mitbringst

Warum QUMEA?

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