Lead Business Analyst

5 days ago

Perth, Australia ROBERT WALTERS AUSTRALIA Full time

The Lead Business Analyst is responsible for leading business analysis activities across our Software as a Medical Device (SAMD) portfolio. This role is pivotal in driving process excellence, regulatory alignment, and continuous improvement. The role works closely with the Product Owner, Quality, Regulatory, and Development teams to ensure business needs are translated into compliant, efficient, and scalable solutions. - Process Leadership & Continuous Improvement - Regulatory & Quality Alignment - Stakeholder Engagement & Communication - Requirements Management - Governance & Documentation - Leadership & Capability Development Qualifications 10 years’ experience as a Business Analyst, including leadership of complex or cross‑functional projects. 1‑2 years’ experience as a Senior or Lead Business Analyst in a regulated software or medical device environment. Strong understanding of SAMD, design controls, development life cycle and associated regulatory frameworks. Experience with business process modelling, Lean, Six Sigma, or similar methodologies. Excellent communication, facilitation, and stakeholder management skills. Proven experience with Agile/Scrum methodologies and tools (e.g., JIRA, Jama, etc.). Experience with traceability tools and documentation systems used in regulated environments. Strong background in software or product development, ideally within MedTech, HealthTech, or another regulated industry. Proven ability to analyse complex systems and processes and translate them into actionable requirements. Excellent communication and stakeholder management skills. Proficiency with Jira, Confluence (or similar tools). Experience with Software as a Medical Device (SaMD) development or other highly regulated environment. Familiarity with ISO 13485 and FDA regulations. About the Job Aboriginal and Torres Strait Islander Peoples are encouraged to apply. To apply, please click "Apply" or contact Callum Salmon on 08 9266 0945 or callum.salmon@robertwalters.com.au for a confidential discussion. Contract Type: Permanent Specialism: Project Services & Transformation Focus: Agile Salary: AUD150,000 - AUD165,000 per annum Industry: IT Workplace Type: Hybrid Experience Level: Senior Management Location: Perth CBD FULL_TIME Job Reference: 9RW831-C89FBE67 Date posted: 28 October 2025 Consultant: Callum Salmon #J-18808-Ljbffr

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