Senior Business Systems Analyst
Creative Capsule (company site, opens in a new tab)12+ yrsGoaOn-siteDirect career pageEst. 20–35 LPA
Posted 20h ago
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Job description
Structured overview of role & requirements
About This Role
- Understand and translate complex client business needs into precise, actionable technical specifications with a focus on SaaS and healthcare technology contexts.
- Lead requirements documentation and spec-driven development processes, including AI-accelerated prototyping, to ensure alignment across product managers, UX, development teams, and compliance with EU MDR regulations.
- Manage regulatory compliance for medical device software, establishing traceability, risk management, and software lifecycle processes to meet MDR and related standards from project initiation through delivery.
Minimum Requirements
- Minimum 12 years of relevant business analysis experience, preferably in SaaS environments.
- Direct involvement in at least one full project cycle for medical device software or regulated healthcare software with requirements, traceability, and verification responsibilities.
- Working knowledge of EU Medical Device Regulation 2017/745 and supporting standards IEC 62304, ISO 14971, IEC 62366-1, with ability to implement compliant software lifecycle practices.
- Experience using AI tools for rapid prototyping and Spec-Driven Development; proficiency with wireframing/design tools like Figma; professional English communication skills.
Ideal Candidate Profile
- Experienced in managing complex, regulated healthcare software projects, especially involving SaaS platforms and EU/Swiss medical regulations.
- Skilled at cross-functional stakeholder communication and negotiation, capable of advancing requirements clarity and alignment across multi-disciplinary teams internationally.
- Practiced in applying audit-ready documentation, traceability matrices, and risk management integrated with Agile/Spec-Driven Development workflows in regulated software environments.