Regulated Medical Device Software Product Owner

AIATELLA; Helsinki; On-site; EUR 70,000 - 110,000; Full time

Job summary

AIATELLA is seeking a Product Owner to own our medical device software and its regulatory documentation. You will manage design controls and prepare EU MDR and FDA submissions, while connecting clinical and technical teams to align roadmaps.

You will lead PMS and release documentation, support post-market surveillance, and drive prioritisation across ML, backend and frontend development. On-site presence in Helsinki is required.

Qualifications

• PO experience with regulated medical device software
• Experience writing technical documentation for medical devices
• Familiar with IEC 62304, ISO 13485, ISO 14971 and EU MDR controls
• Experience collaborating with clinicians
• Strong technical writing skills and attention to detail

Responsibilities

• Own the device's technical documentation: file, DHF, requirements and traceability
• Lead design controls: user needs, design inputs/outputs, verification and validation plans
• Prepare product and software documentation for EU MDR and FDA submissions
• Contribute to risk management (ISO 14971) and usability files (IEC 62366)
• Own PMS documentation: PMS plans/reports, PMCF and safety reporting
• Own release documentation and software change control
• Oversee product pipeline and roadmap across all products
• Bridge clinical and technical teams, translating clinical needs into requirements
• Engage customers, advisors and clinicians to understand needs
• Support founders in prioritising product resources
• Manage feature prioritisation across ML, backend and frontend
• Drive user story creation and sprint planning
• Support pilot sites as the product goes live

Skills

Product ownership

Regulated medical device

Technical writing

Agile development

Stakeholder management

Clinical collaboration

Tools

FastAPI

PostgreSQL

Docker

Kubernetes

CI/CD

Job description

AIATELLA is seeking a Product Owner to own our medical device software and its regulatory documentation. You will manage design controls and prepare EU MDR and FDA submissions, while connecting clinical and technical teams to align roadmaps.

You will lead PMS and release documentation, support post-market surveillance, and drive prioritisation across ML, backend and frontend development. On-site presence in Helsinki is required.