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Senior, niche-regulatory data role despite Tier-1 brand reduces competition.
Regulatory medical device requirements (GxP, FDA) strongly limit cross-industry transferability.
Explicit 8–10 years, mandatory Azure/SQL/Python and GxP/FDA compliance requirements make filters strict.
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Develop, validate, and maintain high-quality analytics products including datasets, tables, figures, listings, dashboards, and reports supporting Product Safety & Quality, Regulatory, Clinical, and Operational functions.
Design and build scalable data transformations, semantic models, and pipelines using Azure Data Lake, Data Factory, Microsoft Fabric/Synapse, SQL, and Python to deliver trusted analytical datasets.
Ensure compliance with healthcare regulations (GxP, FDA 21 CFR Part 11, GDPR) and data governance principles while producing transparent, reproducible, and audit-ready analytical outputs with clear technical documentation.
Bachelor's or Master's degree in Information Management, Information Systems, Computer Science, Data Analytics, or equivalent.
8-10 years of relevant experience in data analytics, data modeling, or equivalent fields.
Strong experience with Azure data technologies (Azure Data Lake, Azure Data Factory, Microsoft Fabric/Synapse), SQL, and Python.
Knowledge of regulatory compliance requirements such as GxP, FDA 21 CFR Part 11, GDPR, and quality system standards.
Experienced in a regulated medical device or healthcare environment dealing with regulatory and quality data requirements.
Proficient at applying advanced statistical methods and machine learning techniques to analyze complex datasets to drive strategic and operational decisions.
Able to work collaboratively with cross-functional teams including Quality, Regulatory, Clinical, IT, Data Engineering, and business stakeholders to deliver validated and compliant analytical solutions.