Regulatory Submissions & Systems Specialist - SEA

Medtronic; Taguig; On-site; PHP 400,000 - 700,000; Full time

Job summary

Medtronic Philippines is seeking an Associate Regulatory Affairs Systems Specialist to support regulatory operations across Southeast Asia. You will manage regulatory submissions, maintain documentation, and coordinate with cross-functional teams to ensure on-time registrations.

This role emphasizes accuracy, process compliance, and data integrity within regulatory systems, delivering timely updates and supporting lifecycle maintenance for country-specific requirements.

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 simultaneously.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Strong written and verbal communication supporting cross-functional collaboration.

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 CFGs, FSCs, and ISO certificates.
• Coordinate translation activities and ensure required submission materials are compliant with local requirements.
• Support regulatory administrative activities and maintain accurate regulatory records and documentation.

Skills

Regulatory knowledge

Documentation management

Cross-functional collaboration

Communication

Education

Bachelor's degree in related field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Medtronic Philippines is seeking an Associate Regulatory Affairs Systems Specialist to support regulatory operations across Southeast Asia. You will manage regulatory submissions, maintain documentation, and coordinate with cross-functional teams to ensure on-time registrations.

This role emphasizes accuracy, process compliance, and data integrity within regulatory systems, delivering timely updates and supporting lifecycle maintenance for country-specific requirements.