Regulatory Systems & Submissions Specialist — SEA

medtronic; Philippines; On-site; PHP 520,000 - 760,000; Full time

Job summary

Medtronic, a global leader in healthcare technology, seeks an Associate Regulatory Affairs Systems Specialist to support Southeast Asia regulatory operations. You will manage regulatory submission workflows, maintain documentation, and coordinate with cross-functional teams to ensure timely registrations and lifecycle maintenance.

The role emphasizes data accuracy, system-based processes, and collaboration across operating units to enable compliant product commercialization in the region.

Qualifications

• Bachelor's degree with 1+ years of experience in Regulatory Affairs or related regulated industry.
• Experience managing documentation, records, or data within business systems.
• Experience coordinating multiple projects, deliverables, and deadlines.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Written and verbal communication skills supporting cross-functional collaboration.

Responsibilities

• Coordinate regulatory submission activities, timelines, and project deliverables across 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 activities.
• Partner with Business Units and stakeholders to collect, verify, and maintain required regulatory documentation.
• Request, manage, and track regulatory certificates and legal documents (CFGs, FSCs, ISO).
• Coordinate translation activities and ensure submission materials meet local requirements.
• Support regulatory administrative activities and maintain accurate regulatory records.

Skills

Communication skills

Project coordination

Cross-functional collaboration

Written & verbal communication

Education

Bachelor's degree

Tools

Excel

Word

PowerPoint

Regulatory Information Management (RIM) systems

Document management platforms

Job description

Medtronic, a global leader in healthcare technology, seeks an Associate Regulatory Affairs Systems Specialist to support Southeast Asia regulatory operations. You will manage regulatory submission workflows, maintain documentation, and coordinate with cross-functional teams to ensure timely registrations and lifecycle maintenance.

The role emphasizes data accuracy, system-based processes, and collaboration across operating units to enable compliant product commercialization in the region.