20 beste Stellen als qa in zürich, zh – aktuell auf Personalsuche

Regulatory & Quality Builder, SaMD (40% Now, Ramp-Up to 100%)
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Direkt bewerben
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Regulatory & Quality Builder, SaMD (40% Now, Ramp-Up to 100%)

Aeon -
Winterthur, ZH

Direkt bewerben

Details zur Stelle

Teilzeit | 100%

Qualifikationen

Management-Erfahrung
Schreibfähigkeiten
Englisch
ISO 13485
Deutsch

Vollständige Stellenbeschreibung

About Aeon

Would you like to help flip healthcare in Europe with us from reactive to preventive?

Aeon is redefining preventive healthcare with a medical software platform powered by AI. Our mission is to help people live longer, healthier lives by detecting and predicting disease before symptoms appear.

We are a top-class, hands-on team of serial entrepreneurs, AI researchers, longevity doctors, radiology executives and more.

Backed by strong investment and a successful economic start, Aeon is set to lead the next wave of preventive healthcare in Europe.

About the role

As we evolve our product and move toward formal medical device certification under the EU MDR, we are looking for a hands-on Regulatory & Quality Specialist to build our regulatory foundation from the ground up.

This is not a maintenance role. You will define and implement our regulatory and quality strategy for medical software, shaping how we design, document, and ship our product going forward.

Workload: 40% now, ramp up to 100% in winter 26/27, details negotiable.

Tasks

Own Aeon’s RA/QA roadmap toward our first EU MDR CE mark. You will be the first (and for the first 1–2 years, the only) RA/QA hire, running the program end-to-end with targeted support from external advisors.
Start at 40% and ramp up to 100% in winter 26/27 (negotiable), scaling from foundation-building to certification execution.
Define intended use and classification strategy for Aeon’s medical software platform with AI, including the medical/non-medical boundary and rationale.
Build and operate an ISO 13485-aligned QMS (SOPs, training, document & change control, CAPA, internal audits, management reviews).
Embed design controls, traceability, and risk management into product + engineering workflows without slowing down execution.
Drive technical documentation (Tech File): requirements, risk file, V&V, usability engineering, cybersecurity inputs, and post-market plans.
Establish the clinical/performance evidence strategy and evidence package needed for MDR (incl. claims, evaluation approach, and documentation).
Partner with our AI/engineering team to ensure our AI features are appropriately validated and documented for MDR (clear documentation, change tracking, and monitoring).
Lead Notified Body interactions: readiness, pre-submission, audits, findings management, and closure.

Requirements

Must-haves

Regulatory + quality experience for SaMD
Built (not just maintained) an ISO 13485 QMS in a small team
Comfortable being the first RA/QA hire and driving the program end-to-end
Strong EU MDR and SaMD/software classification understanding
Hands-on MDR technical documentation / Tech File experience
Supplier + external partner management in regulated environments
Able to coordinate adjacent compliance topics (GDPR basics, vendor DPAs, DPIAs) with specialist support when needed
Working knowledge of ISO 13485, IEC 62304, ISO 14971, and IEC 62366
Hands-on: writing SOPs, creating templates, structuring documentation
Notified Body experience (preparation, audits, findings closure)
Pragmatic, startup-minded, and solution-oriented
Clear communicator who can drive adoption across teams
Fluent English (German is a plus)
Swiss work permit or Swiss/EU/EFTA citizenship

Nice to have

Experience in preventive health or digital health startups

Benefits

Real ownership: build Aeon’s regulatory and quality foundation from scratch — and take it all the way to our first CE mark
A rare “builder” mandate with real influence on product, engineering, and company-wide ways of working
Direct collaboration with leadership and a high-trust environment with fast decision-making
Mission-driven work: help shift healthcare from reactive to truly preventive
Hybrid setup in Winterthur, with in-office days on Monday, Tuesday, and Thursday

To apply: Please submit your CV and your answers to the questions in the application form.

For the five text-based questions, please cap your responses to max 5 sentences per question. A cover letter is not required.

We look forward to hearing from you.

Direkt bewerben

Erweiterte Suche

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