Regulatory Systems Associate – Southeast Asia

MPI Medtronic Philippines, Inc; Taguig; On-site; PHP 350,000 - 480,000; Full time

Job summary

Medtronic Philippines, Inc is seeking an Associate Regulatory Affairs Systems Specialist to support regulatory submissions and lifecycle activities in Southeast Asia. You will coordinate projects, maintain regulatory systems, and compile submission packages across markets.

The role involves working with Regulatory Affairs teams, operating units, and cross-functional partners to ensure timely and compliant regulatory submissions and lifecycle maintenance.

Qualifications

• Bachelor's degree in regulatory affairs, regulatory operations, healthcare, medical devices, or a related regulated industry.
• Experience managing documentation, records, or data within business systems.
• Experience coordinating multiple projects, deliverables, and deadlines simultaneously.

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 submission materials meet local requirements.
• Support regulatory administrative activities and maintain accurate regulatory records and documentation.

Skills

Regulatory coordination

Documentation management

Project tracking

Microsoft Office

Education

Bachelor's degree in regulatory affairs, life sciences, or related

Tools

RIM systems

Job description

Medtronic Philippines, Inc is seeking an Associate Regulatory Affairs Systems Specialist to support regulatory submissions and lifecycle activities in Southeast Asia. You will coordinate projects, maintain regulatory systems, and compile submission packages across markets.

The role involves working with Regulatory Affairs teams, operating units, and cross-functional partners to ensure timely and compliant regulatory submissions and lifecycle maintenance.