Specialist- Regulatory Affairs Process Digitalization & AI
Fresenius Medical Care2 months ago
Bengaluru, IndiaMid Level
Responsibilities
- Identify AI-enabled process improvement opportunities across Regulatory Affairs workflows.
- Design, develop, and deploy production-ready AI applications, AI agents, and knowledge assistants.
- Build intelligent document processing solutions for extraction, classification, summarization, comparison, and validation of regulatory documents.
- Develop and optimize Retrieval-Augmented Generation solutions for secure retrieval of regulatory knowledge.
- Apply prompt engineering, output validation, retrieval benchmarking, and AI quality assurance practices.
- Integrate AI solutions with Azure OpenAI, Microsoft Copilot Studio, Microsoft Foundry, AWS Bedrock, Power BI, SharePoint, and Regulatory Affairs systems.
- Develop or maintain workflow automation and KPI dashboards for Regulatory Affairs performance and operational metrics.
- Collaborate with cross-functional teams to translate Regulatory Affairs requirements into scalable AI-enabled solutions.
- Ensure compliance with data governance, security, and responsible AI principles.
- Evaluate emerging AI technologies and recommend solutions for Regulatory Affairs digital transformation.
Requirements
- Experience or capability in developing and deploying production-ready AI applications, agents, and knowledge assistants.
- Knowledge of intelligent document processing for structured and unstructured regulatory documentation.
- Experience building or optimizing Retrieval-Augmented Generation solutions.
- Knowledge of prompt engineering, output validation, retrieval benchmarking, and AI quality assurance.
- Ability to integrate AI solutions with enterprise platforms and systems.
- Understanding of data governance, security, responsible AI, and compliant solution delivery.
- Ability to collaborate with Regulatory Affairs and cross-functional stakeholders to translate business requirements into scalable solutions.
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About Fresenius Medical Care
Fresenius Medical Care develops and sells dialysis machines, dialyzers, and related disposables, and operates in-center and home dialysis clinics for people with chronic kidney disease. Its business combines product sales to healthcare providers with dialysis services reimbursed by insurers and health systems. Founded in 1996 and headquartered in Bad Homburg, Germany, the company is publicly traded in Frankfurt and serves patients and providers worldwide.