Busniess Analyst
Role Overview
The Business Analyst (Medical Devices) plays a key role in bridging business needs, regulatory requirements, and technical delivery within the medical device environment. This role supports end‑to‑end product lifecycle activities, ensuring that business processes, system capabilities, and compliance standards align to deliver safe, effective, and commercially successful medical device solutions.
The Business Analyst will collaborate closely with R&D, Quality/Regulatory, Clinical, Engineering, IT, Operations, and Commercial teams to capture requirements, optimise workflows, and support the development and continuous improvement of medical device products and associated digital solutions.
Key Responsibilities
1. Requirements Gathering & Documentation
- Elicit, analyse, and document business and functional requirements for medical device products, platforms, and supporting systems.
- Translate stakeholder needs into clear specifications, user stories, use cases, and acceptance criteria.
- Ensure requirements comply with relevant standards (e.g., ISO 13485, IEC 62304, ISO 14971).
2. Process Analysis & Improvement
- Map and analyse end‑to‑end business processes relating to product development, manufacturing, quality, and post‑market surveillance.
- Identify opportunities for process optimisation, automation, and standardisation.
- Support change management activities to drive adoption of new processes and systems.
3. Regulatory & Quality Alignment
- Ensure that all requirements and workflows align with medical device regulatory frameworks (FDA, MDR, UKCA).
- Support the creation and maintenance of design controls, DHFs, risk documents, traceability matrices, and other compliance artefacts.
- Collaborate with Quality/RA teams to prepare for audits and submissions.
4. Stakeholder Management
- Act as the liaison between business teams, engineering, QA/RA, and IT.
- Facilitate cross‑functional workshops, decision‑making sessions, and backlog prioritisation.
- Communicate progress, risks, and issues effectively to leadership.
5. Solution Design & Delivery Support
- Partner with product managers, architects, and engineering to define solution designs.
- Support sprint planning, grooming, and UAT preparation.
- Validate that delivered solutions meet requirements and are fully traceable from concept to release.
6. Data & Analytics
- Analyse product performance, quality metrics, and operational data to provide insights and recommendations.
- Support the development of dashboards, KPIs, and reporting frameworks.
FAQs
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