Regulatory & Quality Builder, SaMD (40%)

Winterthur, Zürich
Unbefristet
Vollzeit

2 Tage her

About AeonAeon 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 jobAs 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%, with the potential to grow into a full-time position in the future as the company scales.Tasks

Define and document Aeon’s regulatory pathway under EU MDR, including the software classification rationale
Build and implement a QMS aligned with ISO 13485
Align product development and sprint processes with regulatory requirements
Work closely with design and software engineers to ensure proper documentation and traceability
Establish software lifecycle processes
Define and implement risk management processes
Create and structure technical documentation for CE marking
Prepare the organization for future Notified Body interactions
Act as Aeon’s internal regulatory and quality expert

RequirementsMust-haves

Experience in regulatory affairs and or quality management for SaMD
Experience building or significantly contributing to a QMS, not only maintaining one
Solid understanding of EU MDR and software classification
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
Swiss work permit or Swiss/EU/EFTA citizenship and ability to work from our office in Winterthur

Nice to have

Experience in preventive health or digital health startups

Benefits

Real ownership: build our regulatory foundation from scratch
Direct collaboration with leadership
High-impact role in a health-focused company
A health-focused company culture (including healthy snacks at the office and weekly team CrossFit sessions)

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.AeonAeon is the first multi-modal preventive health platform designed to transform healthcare from reactive to proactive.By combining whole-body MRI with blood data, genetic data, and more, we can detect diseases early and predict health risks with unprecedented accuracy. AI not only boosts diagnostic precision but also helps us reduce costs, making cutting-edge preventive care accessible to everyone.

AEON

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