Sr Data Analyst - Regulatory Compliance Recalls

Job Summary

Medline is hiring a Senior Data Analyst to ensure high levels of data quality, integrity, and governance, enabling product recall, regulatory, and quality data to effectively support business operations and compliance requirements. This role will build high impact analytics, dashboards, and data governance solutions that directly support patient safety and FDA readiness across manufacturing, supply chain, and quality teams.

• Ensure high levels of data quality, integrity, and governance so product recall and regulatory data effectively support business operations and compliance requirements.
• Design, develop, and deliver post‑market surveillance and recall analytics, dashboards, tools, and insights to support patient safety, recall execution, and regulatory compliance.
• Establish and maintain master data standards, procedures, and a recalls reporting framework, including data collection, validation, governance, and a single source of truth aligned with applicable regulations and the Quality Management System.
• Analyze manufacturing, inventory, shipping, distribution, and customer data to identify affected products and customers and ensure end‑to‑end traceability during recall events.
• Support recall execution activities—product holds, inventory containment, scrapping, return‑to‑vendor, and disposition or termination requirements—in partnership with Quality, Manufacturing, Supply Chain, Logistics, Customer Service, and Regulatory Affairs.
• Monitor, track, and report on data quality metrics; perform ongoing analysis, audits, and investigations to identify errors, risks, or gaps and drive corrective and preventive actions.
• Engage with business leaders to assess and communicate the business and regulatory impact of data quality issues or recall process gaps and recommend improvements.
• Identify, lead, and implement continuous improvement initiatives through process mapping, system enhancements, and adoption of best practices.
• Respond to time‑sensitive and escalated data and reporting requests related to recalls, quality events, and regulatory inquiries.
• Support FDA inspections and other regulatory agency inspections or information requests by providing accurate, well‑documented, and timely data.
• Maintain departmental SOPs and documentation related to data management, analytics, and reporting standards.

Education:

Bachelor’s degree in a business‑related field such as business, supply chain, operations, engineering, or information systems.

Work Experience:

4+ years of experience in data management, data analysis, or reporting, with demonstrated experience driving data or tooling improvements from requirements gathering through validation and release. Prior experience working in a regulated industry (medical device, Med Tech, healthcare, pharmaceutical) preferred.

Experience supporting product recalls, post‑market surveillance, quality events, or regulatory compliance activities preferred.

• Proficiency with data manipulation, analytics, and reporting tools including Excel, SQL, Access, and Power BI / Microsoft Fabric.
• Experience developing data collection, automation, and reporting solutions, including use of Power Apps.
• Knowledge of SAP, Smartsheet, and other ERP or reporting platforms.
• Strong understanding of data quality, governance, validation, and audit readiness in regulated environments.
• Ability to analyze complex information, prioritize critical data, and deliver clear, actionable insights.
• Strong communication skills with the ability to translate data for technical and non‑technical stakeholders.
• Experience driving continuous improvement initiatives and implementing process or system enhancements.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• Ability to work independently and provide leadership, coaching, and mentoring to others.

Anticipated salary range: $79,000.00–$ per year. The actual salary will vary based on location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.