Regulatory & Quality Builder, SaMD (40% Now, Ramp-Up to 100%) - #45508

About Aeon

Aeon is redefining preventive healthcare. We combine whole-body MRI, advanced blood biomarkers, and genetic data with AI to detect and predict diseases before symptoms appear. Our mission is to empower people to live longer, healthier lives by shifting healthcare from reactive to proactive.

About the job

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.

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.

• Own Aeon’s regulatory and quality roadmap as we build toward our first EU MDR CE mark. You are the first (and for the first 1–2 years, the only) RAQA hire — expected to run the program end-to-end, with targeted support from external advisors when needed.


• Start at 40% and ramp up to 100% in winter 26/27 (details negotiable), scaling the program from foundation work to full certification execution.


• Define the intended use and classification strategy for Aeon’s product components, including a clear medical vs. non-medical separation and the rationale for our portal, AI models, and internal tooling.


• Build and operate an ISO 13485-aligned QMS (processes, SOPs, training, document control, change control, CAPA, internal audits, management reviews).


• Embed design controls, traceability, and risk management into our product and engineering workflows, without slowing down execution.


• Drive Tech File creation and maintenance: requirements, risk file, verification/validation evidence, usability engineering, cybersecurity inputs, and post-market plans.


• Coordinate key compliance workstreams that intersect with the CE program (GDPR baseline, DPIA/RoPA where needed, vendor DPAs, and EU AI Act readiness), partnering with internal owners and external specialists as required.


• Prepare and lead interactions with the Notified Body: readiness assessments, pre-submission work, audits, findings management, and closing actions to achieve certification.

Must-haves

• Experience in regulatory affairs and quality management for SaMD


• Built an ISO 13485 QMS in a small team - not only maintained one


• Comfortable being the first (and for the first 1–2 years, the only) RAQA hire and driving the program end-to-end


• Solid understanding of EU MDR and SaMD/software classification


• Hands-on experience owning or contributing significantly to MDR technical documentation / Tech File workstreams


• Experience managing suppliers and external partners (vendors, auditors, consultants) in a regulated context


• Ability to coordinate adjacent compliance topics that intersect with the CE program (e.g., GDPR fundamentals, vendor DPAs, DPIAs where required), with targeted specialist support when needed


• Experience working under ISO 13485, IEC 62304, ISO 14971, and IEC 62366 frameworks


• Comfortable working hands-on, including writing SOPs, creating templates, and structuring documentation


• Experience preparing for or working with a Notified Body


• Pragmatic and solution-oriented mindset with an understanding of startup realities


• Strong communication skills and the ability to drive process adherence across teams


• Fluent in English; German is a bonus


• Swiss work permit or Swiss, EU, or EFTA citizenship

Nice to have

• Experience in preventive health or digital health startups

• 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.