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

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