Regulatory Affairs Specialist
Medtronic
- Location
- Memphis, Tennessee, United States of America
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 106 approvals (FY2023)
- Posted
- Aug 25, 2026
Skills
About this role
We anticipate the application window for this opening will close on - 28 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic Neuroscience , we bring innovation, expertise, and purpose together to improve care for people living with neurological, spinal, and chronic pain conditions. Our technologies help restore function, improve quality of life, and support better outcomes for patients around the world. Cranial & Spinal Technologies (CST) advances surgical care for patients with spine and cranial conditions. We develop innovative solutions that help clinicians plan, navigate, and deliver procedures with accuracy, efficiency, and patient outcomes in mind. Check us out on LinkedIn: Medtronic CST The Regulatory Affairs Specialist is responsible for leveraging data, analytics, and digital tools to support Regulatory Affairs strategies, compliance activities, operational excellence, and business decision-making. This role partners with Regulatory Affairs, Quality, R&D, IT, Supply Chain, and other cross-functional teams to collect, analyze, interpret, and visualize regulatory data to improve compliance, data quality, process efficiency, and regulatory intelligence. The RAS transforms complex regulatory data into actionable insights, develops dashboards and metrics, identifies trends and risks, and supports regulatory systems, submissions, registrations, and data governance initiatives.
Primary Responsibilities
Data Analytics & Insights Collect, cleanse, validate, and analyze regulatory data from multiple systems and sources. Develop dashboards, reports, scorecards, and KPIs to support Regulatory Affairs operations and leadership decision-making. Identify trends, risks, bottlenecks, and opportunities for process improvement using data analytics techniques. Conduct root cause analysis and provide data-driven recommendations to improve regulatory compliance and operational effectiveness. Support forecasting, workload analysis, resource planning, and regulatory metrics reporting. Regulatory Data Governance Support regulatory data governance initiatives and ensure data accuracy, consistency, and integrity across systems. Monitor and improve regulatory master data quality. Define, document, and maintain data standards, business rules, and data management processes. Partner with business stakeholders to resolve data discrepancies and implement corrective actions. Systems & Digital Solutions Serve as a business partner for regulatory information management systems and related digital platforms. Support system enhancements, testing, validation activities, and user acceptance testing (UAT). Collaborate with IT and business teams to automate reporting and streamline regulatory processes. Develop Power BI dashboards, analytics solutions, and process automation opportunities. Regulatory Operations Support Support regulatory submission, registration, licensing, and product maintenance activities through data analysis and reporting. Monitor regulatory commitments, filings, renewals, and compliance-related metrics. Assist in regulatory audits, inspections, and compliance assessments through data gathering and reporting. Continuous Improvement Apply Lean, Six Sigma, and process improvement methodologies to improve regulatory workflows. Identify automation opportunities and drive efficiency initiatives. Develop metrics to measure process effectiveness and business outcomes. Cross-Functional Collaboration Partner with Regulatory Affairs SMEs, Data Stewards,