Software Business Analyst

Job Summary: We are seeking a highly skilled Senior Software Business Analyst to drive requirements development for medical device software in a regulated environment. This role serves as the vital link between clinical users, business stakeholders, and software development teams, ensuring solutions meet both user needs and regulatory standards such as FDA, ISO 13485, and IEC 62304. Responsibilities: • Collaborate with cross-functional teams to define and manage software requirements. • Translate complex clinical and business needs into detailed Software Requirements Specifications (SRS). • Serve as the primary liaison between business and technical teams throughout the development lifecycle. • Ensure traceability and alignment of requirements with regulatory and risk management frameworks. • Support validation and verification processes by reviewing test plans and ensuring requirements coverage. • Facilitate change management and impact analysis for evolving requirements. • Participate in audits and contribute to regulatory submissions. • Promote continuous improvement of business analysis and software development practices. Qualifications: • Bachelor’s or Master’s degree in Business, Engineering, Computer Science, Biomedical Engineering, or related field. • 5+ years of business analysis experience, including 2+ years in a senior or lead role. • Proven background in medical device or regulated healthcare software environments. • Strong knowledge of IEC 62304, ISO 13485, FDA Design Controls, and 21 CFR Part 11. • Familiarity with Agile, Scrum, or Waterfall development methodologies. • Proficiency with tools like Jira, Confluence, Azure DevOps, and Jama (highly preferred).