Regulatory & Quality Builder, SaMD, 30-50

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.

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: 3050% with the potential to grow into a full-time position in the future as the company scales.

Tasks

• Define and document Aeons 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 Aeons internal regulatory and quality expert

Requirements

Must-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 or EFTA citizenship

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
• Based 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.