We are seeking an experienced Business Analyst with expertise in Regulatory Affairs and Clinical Affairs within the medical device/MedTech industry. The ideal candidate will analyze business processes, identify opportunities for AI-enabled automation and digital transformation, gather requirements, and collaborate with cross-functional stakeholders to improve operational efficiency while maintaining regulatory compliance.
Key Responsibilities
- Analyze current-state Regulatory Affairs and Clinical Affairs workflows, systems, data, controls, and business processes.
- Identify opportunities for AI, intelligent automation, workflow automation, analytics, and digital transformation.
- Develop business requirements, functional requirements, user stories, acceptance criteria, process maps, and business cases.
- Conduct stakeholder interviews, discovery workshops, requirements reviews, and prioritization sessions.
- Perform gap analysis, root cause analysis, process mapping, and data analysis to identify improvement opportunities.
- Collaborate with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy, and Security teams.
- Document current-state and future-state workflows, business rules, data flows, dependencies, risks, and success metrics.
- Assess proposed solutions for regulatory compliance, data privacy, quality, validation, traceability, and change-management requirements.
- Support solution evaluation, backlog refinement, UAT readiness, implementation planning, and change adoption.
- Prepare executive presentations, reports, dashboards, and recommendations for senior leadership.
- Manage assigned deliverables independently and proactively communicate risks, decisions, and dependencies.
Required Skills and Qualifications
- 3–5 years of relevant Business Analyst experience, with approximately 5 years preferred.
- Minimum 2 years of experience in the medical device/MedTech industry, supporting Regulatory Affairs and/or Clinical Affairs.
- Strong understanding of regulated medical device processes, quality management systems, documentation controls, and regulatory requirements.
- Experience in business requirements gathering, functional requirements documentation, user stories, acceptance criteria, and process mapping.
- Knowledge of AI, intelligent automation, workflow automation, analytics, and digital transformation.
- Experience with process mapping, gap analysis, root cause analysis, data analysis, and KPI definition.
- Ability to identify automation opportunities and evaluate business value, feasibility, and regulatory impact.
- Proficiency in Microsoft Excel, PowerPoint, Word, Visio, or equivalent process-mapping tools.
- Experience with Agile methodologies and requirements management tools is preferred.
- Excellent written and verbal communication skills, with the ability to engage stakeholders from individual contributors to VP-level leadership.