Sr Data Analyst - Regulatory Compliance Recalls
7 days ago
New York
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 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. Job Description Major 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. Minimum Job Requirements 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. 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. Knowledge / Skills / Abilities 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. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. 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.
