Healthcare Quality & Regulatory Automation Analyst
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
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 companys 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
Bachelors 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 )
Required Skills:
Healthcare Quality & Regulatory Automation Analyst
Required Education:
diploma / degree
