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

**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.