Regulatory Information Management Analyst
MedTechRegulatory Affairsinform
Job description
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 Clinical and Regulatory Solutions (CRS) supports Medtronic’s global regulatory operations by providing technology, data, and process capabilities that enable efficient management of regulatory information throughout the product lifecycle. The team partners with Regulatory Affairs, Information Technology, and cross-functional stakeholders to maintain data quality, support business processes, and advance digital transformation initiatives across the regulatory environment. This position is based in Bratislava, Slovakia and operates in a Remote work model, supporting global users across multiple regions and time zones. No travel is required for this role. As a Technology Enablement Specialist, you will support Regulatory Information Management (RIM) systems used across Medtronic’s global regulatory organization. This role contributes to the implementation and ongoing support of a modernized RIM platform by maintaining high-quality regulatory data, supporting system users, and partnering with Regulatory Affairs and Information Technology teams to improve processes and system effectiveness. Primary Responsibilities Serve as a primary point of contact for internal users of Regulatory Information Management systems, providing support and issue resolution. Create and maintain submission structures, regulatory records, and business data attributes within the RIM environment. Build and manage system templates, including submission assembly templates and related configurations. Perform data entry, data cleansing, and master data governance activities to ensure data accuracy and integrity. Support implementation and sustainment activities associated with the RIM modernization program. Participate in project meetings, providing status updates, identifying risks, and supporting mitigation activities for assigned deliverables. Monitor adherence to RIM standards, procedures, and work instructions to support regulatory compliance requirements. Identify opportunities to improve system processes, data quality, and user experience through continuous improvement initiatives. Required Qualifications Bachelor's degree in Life Sciences, Public Health, Business, or a related discipline and 2+ years of experience supporting Regulatory Information Management systems, Regulatory Affairs processes, or master data management; or Master's degree and 1+ year of relevant experience. Experience maintaining business data, regulatory records, or master data in enterprise systems. Experience supporting end users, managing requests, or resolving system-related issues. Proficiency using Microsoft Office applications, including Excel. Demonstrated ability to manage multiple assignments while maintaining accuracy and attention to detail. Preferred Qualifications Experience working with Regulatory Information Management platforms in a medical device, pharmaceutical, or life sciences environment. Knowledge of the regulatory affairs lifecycle and regulatory submission processes. Experience with data governance, data quality management, or system implementation projects. Experience collaborating with cross-functional teams including Regulatory Affairs and Information Technology. Experience identifying and implementing process improvements that enhance system effectiveness or data quality. Physical Job Requirements The above statements are intended to
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