Sr Data Analyst - Regulatory Compliance Recalls

Medline Industries, LP

2d•Onsite

About The Position

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 is an exciting opportunity to build high impact analytics, dashboards, and data governance solutions that directly support patient safety and FDA readiness across manufacturing, supply chain, and quality teams. Ideal for a hands on, senior analyst who thrives in regulated environments and wants to make a visible, enterprise level impact.

Requirements

Bachelor’s degree in a business‑related field such as business, supply chain, operations, engineering, or information systems.
4+ years of experience in data management, data analysis, or reporting.
Demonstrated experience driving data or tooling improvements from requirements gathering through validation and release.
Prior experience working in a regulated industry required (medical device, MedTech, healthcare, pharmaceutical, or similar strongly preferred).
Proven ability to work cross‑functionally and manage multiple priorities while delivering accurate results within tight timelines.
Demonstrated knowledge of data manipulation, analytics, and reporting tools including Excel, SQL, Access, and Power BI / Microsoft Fabric.
Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
Ability to work independently and provide leadership, coaching, and mentoring to others.

Nice To Haves

Experience supporting product recalls, post‑market surveillance, quality events, or regulatory compliance activities preferred.
Experience developing data collection, automation, and reporting solutions, including use of Power Apps.
Knowledge and experience with 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.

Responsibilities

Ensure high levels of data quality, integrity, and governance so product recall, regulatory, and quality 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 (QMS).
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—including 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.