Lead Business Analyst
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
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Essential: 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 trace ability 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). Desirable: Experience with Software as a Medical Device (SaMD) development or other highly regulated environment. Familiarity with ISO 13485 and FDA regulations. |
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.
About the job
Contract Type: Permanent
Specialism: Project Services & Transformation
Focus: Agile
Industry: IT
Salary: AUD150,000 - AUD165,000 per annum
Workplace Type: Hybrid
Experience Level: Senior Management
Location: Perth CBD
FULL_TIMEJob Reference: 9RW831-C89FBE67
Date posted: 28 October 2025
Consultant: Callum Salmon
perth project-services-and-transformation/agile 2025-10-28 2025-11-27 it Perth CBD Western Australia AU AUD 150000 165000 165000 YEAR Robert Walters https://www.robertwalters.com.au https://www.robertwalters.com.au/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true