Healthcare Quality & Regulatory Automation Analyst

Position summary

Act as a technical expert in healthcare quality and regulatory analytics. Combine advanced quantitative analysis, data engineering, and quality system expertise to build stakeholder-specific reporting, develop AI-enabled quality tools, and integrate/manage third-party quality applications to support compliance, continuous improvement, and executive decision-making.

Key responsibilities (primary)

• Perform advanced quantitative data analysis: build statistical and machine learning models for trend detection, root-cause analysis, forecasting, anomaly detection, and risk stratification

• Design, build, and maintain stakeholder-specific dashboards and reports (executive, regulatory) using Power BI tools and data visualization best practices; deliver actionable insights and data storytelling.

• Develop and maintain quality tools and automations using AI/ML/LLM technologies (NLP for document classification/summarization, automated quality checks,

predictive analytics, chat assistants for SOP/QMS guidance).

• Lead integration and lifecycle management of third-party quality software: requirements gathering, vendor coordination, configuration, data integration, testing, release coordination, and ongoing support.

• Utilize current and emerging technologies in evaluating trends to business models and healthcare quality processes

• Develop insights and translate information into actionable initiatives to ensure business outcomes

• Lead and support projects through the application of technical expertise including conceptualization, planning, design, implementation and support of quality assurance processes, systems, and quality technology solutions

• Evaluate and monitor healthcare quality processes and systems to identify areas for continuous improvement and transformation ensuring global excellence

• Initiate and lead the development of reports for key stakeholders, including executive management, using data storytelling and visualization.

• Develop and execute tools to enhance services and deliver training for internal customers or vendors on analytics outputs, tools, and integrated systems.

• Gather and consolidate regulatory and business requirements into convert them into technical specifications and implement monitoring to ensure ongoing compliance with company’s internal policies and relevant regional and local regulations.

• Develop and maintain data validation, models, and metadata; routinely assess model performance and recalibrate as required.

• Lead end-to-end analytics projects: planning, stakeholder alignment, implementation, and post-implementation reviews; document methods and SOPs.

• Support audit readiness and provide analytics-driven evidence for regulatory submissions, inspections, and internal quality reviews.

• Identify opportunities for process improvement and automation in quality workflows, pilot new technologies and scale successful solutions.

Additional responsibilities (as needed)

• Provide subject-matter expertise for cross-functional programs and global initiatives.

• Manage vendor relationships and service-level expectations for third-party tools.

• Participate in career progression and mentoring for junior analysts.

Required skills and experience

• Bachelor's degree in Statistics, Data Science, Biostatistics, Engineering, Computer Science, Information Technology, Healthcare Analytics, or related field (or equivalent experience).

• Strong quantitative and statistical skills; proficiency in data science libraries and tools

• Experience building dashboards and visualizations with tools such as Power BI, Tableau, Looker, or equivalent.

• Hands-on experience integrating and managing third-party quality/GxP systems (MasterControl, Synthesis, ServiceNow) or similar QMS/issue tracking platforms.

• Experience working with cloud platforms, databases (SQL, NoSQL), ETL tools, and APIs.

• Practical experience applying AI/ML and prompt engineering for LLMs to automate quality processes, extract insights from unstructured documents, or create assistant workflows.

• Strong data validation, data modeling, and data governance understanding.

• Excellent communication and data storytelling skills; able to translate technical findings into concise recommendations for executives.

• Experience in a regulated environment (healthcare, life sciences, medical devices, or similar) strongly preferred.

• Demonstrated ability to work cross-functionally and manage vendor/IT relationships.

Preferred

• Certifications in data analytics, machine learning, or quality management.

• Prior experience with global operations or multi-regional regulatory frameworks.

Level expectations and experience guidelines

• 3-4 years relevant experience; independently manages projects and provides expert input, recognized expert, leads complex programs with high autonomy.

Core competencies

• Analytical thinking, accuracy, attention to detail, numerical skills.

• Planning and organizing, project management, stakeholder alignment.

• Statistical knowledge, data modeling, visualization skills, automation

• Vendor and cross-functional collaboration, training and documentation abilities.

Technical requirements

• Proficiency with Microsoft Office and web-based applications.

• Familiarity with automation and orchestration tools; experience deploying AI/ML models into production.

• Language: strong written and spoken English.

Compliance and other

• Ensure ongoing compliance with company processes, regional/local legislation, and external regulations.

• May be required to perform other duties as assigned; role can involve regional and global activities

Working Hours:

Mon to Fri 9am - 6pm ( 1 day hybrid )