Shape the Quality and Regulatory Backbone of AI That Improves Children's Healthcare Worldwide
Join a dedicated team at the forefront of radiology. At Visiana, we develop AI-driven software that delivers precise, standardized skeletal maturity assessments for children worldwide. Our flagship SaMD, BoneXpert, is trusted by hospitals and research groups across the globe.
We are looking for a QA/RA specialist – with IT/Systems focus who can get hands-on with our quality processes, device life cycle, change control, handling of non-conformities, and CAPAs, while also helping us stay ahead of evolving regulatory requirements across the markets we operate in, and bringing automation and better internal systems to the processes that benefit from it. It's a broad, hands-on role for someone who wants to develop further expertise in medical device regulatory practice while also having an eye for systems, tooling, and automation.
The Role
This is a broad role with two connected sides. The larger part is regulatory and quality-focused: you'll be hands-on with the device life cycle process, support how our software is specified, tested, verified, and documented to medical device standards, handle change control cases, non-conformities, and CAPA processes, help track and implement new or revised regulatory requirements across our markets, and help keep our technical, verification, and risk documentation accurate, structured, and traceable across our various submissions.
The second part connects you to internal systems and IT: you'll help design and refine how work flows across the company, build and maintain the tools and infrastructure Visiana runs on, connect and integrate the systems the team relies on, and bring automation into recurring QA/RA and operational work where it genuinely saves time and improves accuracy, while keeping human review and approval as the control where it matters.
You'll report to the QA/RA Director, with a dotted line to the Development Director.
Examples of What You Might Work On
- Processing and progressing change cases through our change control board, ensuring impact assessments and documentation are complete and traceable.
- Investigating non-conformities, driving root cause analysis, and following CAPA through to closure and effectiveness checks.
- Monitoring regulatory publications, guidance documents, and standards updates (e.g. MDCG guidance, EU AI Act, FDA guidance, other national requirements) and assessing their impact on our QMS, product and documentation.
- Supporting cross-document consistency reviews across technical documentation packages ahead of submissions.
- Helping maintain and update QMS documentation, SOPs, and Confluence-based regulatory intelligence pages as standards and regulations evolve.
- Automating recurring QA/RA reporting and processing (e.g. complaints, non-conformances, audit findings) so it becomes self-maintained rather than manual.
- Building tools for scraping details from websites and presenting them internally in a structured way for filtering and review for example, tracking regulatory publications or competitor information.
- Creating dashboards that automatically catch data-entry errors and inconsistencies across internal data sources.
- Setting up automated testing environments that make our software verification faster and more repeatable.
Key Responsibilities
- Change Control: Own or co-own change cases end to end, assessing impact, coordinating input, and ensuring changes are properly documented and traceable.
- Non-Conformities & CAPA: Investigate non-conformities hands-on, support root cause analysis, and drive CAPA actions through to effective closure.
- Regulatory Intelligence & Implementation: Track new and revised regulatory requirements across the markets we operate in, assess their impact, and help implement the resulting changes to our QMS, technical files, and processes.
- Regulatory & Quality Documentation: Help maintain and improve technical files, verification records, risk management documentation, and QMS records, ensuring they stay accurate, structured, and traceable to applicable regulatory requirements
- Automation: Bring automation to routine and time-consuming tasks, freeing colleagues to focus on higher-value work, while keeping human review and approval as the control where it matters.
- Internal Systems & Integration: Build and integrate internal systems and connect tools where it supports workflows or company operations more broadly.
What We Look For
We value strong regulatory/quality instincts paired with technical ability and IT. You don't need to tick every box, but we are looking for:
- Experience: Professional experience, preferably at least 3 years of experience in QA/RA, medical device quality systems, and related regulated field, ideally combined with comfort around technical tooling, systems, or automation.
- Regulatory awareness: Familiarity with ISO 13485, IEC 62304, ISO 14971, and EU MDR / FDA frameworks, and comfort tracking regulatory change across jurisdictions.
- Precision: An eye for detail and consistency, someone who notices when numbers, terminology, or claims don't line up across documents.
- Breadth: Comfort moving between documentation-heavy QA/RA work and technical/automation tasks, with the ability to see how the pieces fit together.
- Ownership: A proactive, self-managing approach. You notice what could work better and take the initiative to improve it, rather than waiting to be told.
- Modern tooling: Enthusiasm for building with modern technology. Using AI assistants and automation as part of how we work, with the judgment to know when human review matters most.
- Communication: Strong English skills, written and spoken.
Why Join Visiana?
- Purpose-Driven Work: Contribute to a market-leading AI medical device that is already improving care in pediatric growth and endocrinology.
- Influence: We are a lean, ambitious team where your work directly shapes how the whole company operates.
- Growth: Gain hands-on expertise across regulatory practice, quality systems, and applied automation.
- Flexibility: Hybrid workplace (at least 3-4 days per week in the office) and a broad role with the freedom to shape your own responsibilities in an international, collaborative environment.
Application & Process
We will begin interviewing candidates at the end of August. We still encourage you to apply early as we review applications as they arrive.
About Visiana and BoneXpert
Visiana is located in Hørsholm and is a well-managed Danish company that combines advanced technology with established clinical and commercial value. Our software medical device, BoneXpert, is used by more than 300 hospitals across Europe for the automatic assessment of bone age.
Visiana's BoneXpert software automates the interpretation of pediatric hand X-rays to determine bone age, it replaces manual, subjective readings with accurate, standardized AI analysis, supporting critical decisions in pediatric growth and development.
