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Quality & Regulatory Operations Manager (Company-wide Compliance) (m/f/d)

QUMEA AG
Solothurn, SO

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Détails de l'emploi

Temps partiel | 100%

Description complète du poste

Your 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.
We already have CE-marked medical device functionality in the market, with more regulated features on the way. We treat regulatory as a deliberate strength, and we now need a dedicated owner for it.

The role in one sentence
You own QUMEA's company-wide quality and regulatory framework, the QMS, audits, certifications, risk, supplier and security governance, and you make compliance a living part of how the whole company works.

Why this role matters
Today our quality system exists but does not yet get the dedicated focus it needs, and it is not yet woven into the daily way people work across teams. As we scale across markets, that gap becomes a real risk. This is a build-and-embed role: the documentation itself is increasingly tool- and AI-assisted, so the heart of the job is change management, getting every team, from sensor commissioning to engineering to sales, to work in a process-compliant way without losing our pace.

Your job in detail

What you will own

The ISO 13485 quality management system, company-wide. You operate and evolve the QMS so it is scalable and audit-ready, and so it reflects how we actually work, not a binder on a shelf.
MDR and regulatory governance. You are our internal authority on medical device regulation and coordinate certifications, regulatory governance and customer regulatory requirements across markets, including the Notified Body relationship.
Audits and CAPAs. You prepare and run internal and external audits and own the CAPA process.
Risk management. You lead risk management per ISO 14971 and embed it into how decisions get made and documented.
Supplier and security-process governance. You own supplier qualification and the regulatory side of our security processes, working closely with our CIO on the ISO 27001 ISMS so quality, regulatory and information security share one governance and document-control backbone.
Change management across the company. You design the processes, define who does what, and bring people along with hands-on guidance and clear one-pagers. This is the core of the role.
The compliance cadence. You set and run the recurring reviews (monthly, quarterly, annual) where the right people make and document the right decisions.

What you bring to the table

Must-haves

Senior quality and regulatory professional who knows MDR and ISO 13485 cold and has applied them in practice.
A track record of successfully passing audits and certifications (Notified Body audits, ISO 13485), ideally as the person who got an organisation through them.
Hands-on QMS implementation experience: you have built or substantially rebuilt a quality system, not only maintained one.
Demonstrated ability to lead change management across an organisation, getting non-regulatory people to adopt and keep to new ways of working.
Solid command of risk management (ISO 14971) and an appreciation for how ISO 27001 / information security fits the picture.
Structured, self-driven, persuasive and good with people. You will spend as much time convincing colleagues as writing documents.

Strongly preferred

Experience in Software as a Medical Device and software / SaaS-delivered medical products, including cloud-hosted solutions.
Exposure to bringing new regulated functions to market and to multi-market regulatory requirements.
Familiarity with the Swiss and EU landscape (Swissmedic, EU markets) and medical device data-protection considerations (nDSG/GDPR).
Comfort with modern, AI-assisted documentation and tooling.

Why QUMEA?

Genuine ownership of the company-wide quality and regulatory function: a build role, not a maintenance role.
A seat where it counts: you work directly with our CIO/PRRC, CTPO and CEO.
A meaningful product and a company that wants to do regulatory the serious way.
A pragmatic, fast-moving Swiss MedTech environment that is deliberately investing in doing this right.

Application

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

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.

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Your job in detail

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Why QUMEA?

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