Senior Data Analyst – Regulatory Compliance, Recalls

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🕒 il y a 1 mois

🌽 Illinois – Distant

🌽 Illinois – Remote

💵 $79 000 - $119 000 / an

⏰ Temps Plein

🟠 Senior

📉 Analyste de Données

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Medline Industries, LP

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1910

⚕️ Assurance santé

💊 Pharmaceutique

💰 Private Equity Round en 2021-06

Healthcare Insurance • Pharmaceuticals

Medline Industries, LP est une entreprise leader dans le domaine de la santé, axée sur l'amélioration des résultats cliniques, financiers et opérationnels pour ses clients. La société offre une vaste gamme de plus de 335 000 produits médicaux et dispose d'importantes capacités d'entreposage avec plus de 2,6 millions de mètres carrés d'espace. Avec une présence mondiale significative de 43 000 employés, Medline propose des solutions agiles et évolutives sur tous les points de soins, atteignant un taux de livraison le lendemain de 95 % aux États-Unis. La mission de l'entreprise est d'améliorer la prestation de soins de santé en fournissant des produits supérieurs, une résilience de la chaîne d'approvisionnement et une expertise clinique, tout en favorisant de solides relations avec les clients grâce à des solutions sur mesure et orientées vers la résolution de problèmes.

Description

• 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

🎯 Exigences

• 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) • Experience supporting product recalls, post‑market surveillance, quality events, or regulatory compliance activities 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 • 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 • Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint • Ability to work independently and provide leadership, coaching, and mentoring to others

🏖️ Avantages

• health insurance • life and disability • 401(k) contributions • paid time off • access to the Employee Assistance Program • Employee Resource Groups • Employee Service Corp