Specialist- Regulatory Affairs Process Digitalization & AI
Fresenius Medical Care25 days 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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