Business Analyst

This is a fully remote role and does not require you to be based in the U.S., as long as you have strong overlap with Eastern Time (U.S.) working hours

At AdvaHealth Solutions, we’re reimagining the future of healthcare technology — streamlining clinical workflows, improving diagnostic accuracy, and enabling smarter, connected care. Our cloud-based platform integrates seamlessly with EHRs, imaging systems, and partner ecosystems to support data-driven, interoperable healthcare.

We’re redefining how clinicians interact with medical images. Our next-generation imaging platform combines intuitive design, advanced cloud technologies, and strong system integrations to enhance diagnostic efficiency and patient outcomes. We’re a mission-driven team building solutions that empower radiologists, technologists, and healthcare professionals around the world.

We’re seeking a skilled and detail-oriented Business Analyst to join our medical imaging product team. In this role, you’ll collaborate with clinical and technical stakeholders to translate user needs, regulatory requirements, and product goals into clear, traceable software specifications. Your work will directly support the development of our diagnostic imaging viewer and help ensure compliance with FDA and international standards.

You’ll play a critical role in shaping meaningful, clinically impactful features — improving everyday workflows for healthcare providers and the patients they serve.

• Collaborate with Product Directors, Radiologists, Clinical Specialists, and other stakeholders to gather, document, and validate software requirements for imaging viewer features (e.g., hanging protocols, annotations, measurements, 3D reconstructions).
• Conduct workflow analysis, usability sessions, and clinical interviews to understand user needs.
• Translate findings into epics, user stories, acceptance criteria, and wireframe guidance.
• Maintain traceability from user needs to verification in support of FDA submissions and ongoing design control.

• Author and manage Software Requirements Specifications (SRS), User Needs, and other controlled documents in alignment with IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
• Support internal and external audits by ensuring documentation completeness, consistency, and traceability.
• Contribute to design input documentation for regulatory submissions including 510(k).

• Partner with UX designers, engineers, QA, and regulatory teams throughout the product lifecycle.
• Facilitate cross-functional sessions to align on feature scope, clinical value, and regulatory impact.
• Serve as a liaison between technical and clinical stakeholders to ensure alignment on priorities and risk.

• Work with QA to ensure test cases reflect user needs and design inputs.
• Support UAT planning and execution, gathering structured radiologist feedback.
• Coordinate with clinical affairs on validation studies and pilot feedback cycles.

• Create and maintain user documentation, workflow diagrams, training materials, and release notes.
• Ensure continuity of knowledge through controlled updates to requirements and related artifacts across product iterations.

• Bachelor’s degree in biomedical engineering, Health Informatics, Computer Science, Technical Writing, or related field.
• 3+ years’ experience as a Business Analyst or Product Analyst in a regulated software or healthcare environment.
• Familiarity with radiology workflows, DICOM, and medical imaging standards.
• Proficiency in requirement management and documentation tools (e.g., Jira, Confluence, Azure DevOps).
• Experience with FDA-compliant software development and design control processes.

• Direct experience working on FDA-cleared medical imaging devices or platforms.
• Experience interfacing with radiologists or PACS administrators.
• Understanding of healthcare interoperability standards (HL7, FHIR).
• Exposure to human factors engineering, clinical validation, or usability testing in diagnostic environments.

• Be part of a mission-driven company innovating in the radiology and medical imaging space.
• Work with clinical experts and passionate engineers to shape tools that directly impact patient care.
• Help ensure our viewer software meets the highest standards of usability, safety, and compliance in a fast-evolving healthcare ecosystem.

Ready to join our team? Apply via the link below or send your application directly to careers@advahealthsolutions.com.