Associate Regulatory Affairs Systems Specialist

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About the role

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 The Regulatory Affairs function supports product registration, regulatory maintenance, and compliance activities across Southeast Asia. The team partners with Regulatory Affairs professionals, Operating Units, and cross-functional stakeholders to coordinate submissions, maintain regulatory documentation, and support market access activities that enable products to be commercialized and remain compliant with local regulatory requirements. The Associate Regulatory Affairs Systems Specialist supports regulatory operations through the management of regulatory systems, submission workflows, documentation tracking, and administrative processes. The role contributes to the timely execution of regulatory activities by ensuring data accuracy, process compliance, and effective coordination across multiple stakeholders. The Associate Regulatory Affairs Systems Specialist supports regulatory submission and registration activities across Southeast Asia by coordinating regulatory projects, maintaining regulatory systems, preparing submission documentation, tracking deliverables, and supporting compliance with country-specific regulatory requirements. This role collaborates with Regulatory Affairs teams, Operating Units, and cross-functional partners to help ensure timely and accurate regulatory submissions and product lifecycle maintenance activities.     Primary Responsibilities : • Coordinate regulatory submission activities, timelines, and project deliverables across multiple Southeast Asia markets. • Create, update, and maintain regulatory applications, events, records, and tasks within regulatory systems. • Prepare, compile, and organize regulatory dossiers and submission packages for product registrations, renewals, and change submissions. • Track submission status and provide timely updates on regulatory projects and assigned activities. • Partner with Business Units and stakeholders to collect, verify, and maintain required regulatory documentation. • Request, manage, and track regulatory certificates and legal documents, including Certificates to Foreign Governments (CFGs), Free Sales Certificates (FSCs), and International Organization for Standardization (ISO) certificates. • Coordinate translation activities and ensure required submission materials are available and compliant with local requirements. • Support regulatory administrative activities and maintain accurate regulatory records and documentation. Required Qualifications : • Bachelor's degree with 1+ years of experience in Regulatory Affairs, Regulatory Operations, Healthcare, Medical Devices, Life Sciences, or a related regulated industry. • Experience managing documentation, records, or data within business systems. • Experience coordinating multiple projects, deliverables, and deadlines simultaneously. • Proficiency in Microsoft Excel, Word, and PowerPoint. • Written and verbal communication skills supporting cross-functional stakeholder collaboration. Preferred Qualifications: • Experience supporting medical device, pharmaceutical, biotechnology, or healthcare regulatory processes. • Knowledge of medical device registration, renewal, and product change submission requirements. • Experience with Regulatory Information Management (RIM) systems or document management platforms. •

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