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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.
• Experience preparing technical documentation, regulatory dossiers, or submission packages.
• Experience supporting regional or multinational regulatory operations within Southeast Asia.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).