Project Coordinator, Regulatory Operations

Cochlear; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

Cochlear, a leading medical device company, seeks a Regulatory Operations Project Coordinator to support regulatory operations, content development, localisation, and related operational projects.

This role is responsible for project coordination, workflow administration, documentation management, reporting, and system transaction support to ensure activities are completed accurately, consistently, and on time.

Qualifications

• 1-3 years of experience in project coordination or related roles.
• Excellent attention to detail and communication skills.
• Experience using business systems, workflow tools, spreadsheets, trackers, and document repositories.

Responsibilities

• Maintain project schedules, action lists, trackers, and coordination records to support project delivery.
• Organise project information, prepare materials, and follow up on assigned actions with internal teams and stakeholders.
• Coordinate communications between teams, vendors, reviewers, approvers, and other stakeholders.
• Monitor and follow up on outstanding actions, reviews, approvals, and missing inputs, escalating where required.
• Support multiple projects and workstreams while ensuring priorities and deadlines remain visible and on track.
• Execute routine workflow and system transactions across tools such as Windchill (PLM), TMS, Jira, Confluence, SharePoint, and project tracking platforms.
• Process change requests, status updates, task routing, workflow records, and tracker updates in accordance with established procedures.
• Monitor workflow queues, approvals, tasks, and system activities to ensure timely completion.
• Maintain accurate and consistent records across both manual trackers and system-based workflows.
• Escalate workflow issues, missing information, unclear requests, or stalled activities to the appropriate stakeholders.
• Maintain project trackers, dashboards, status reports, action logs, issue registers, and task lists using accurate information.
• Identify overdue activities, incomplete tasks, missing information, and recurring delays, ensuring they are highlighted to relevant owners.
• Prepare routine project status updates, including progress, upcoming milestones, risks, and open actions.
• Create, update, maintain, and manage project documentation, ensuring proper version control and audit readiness.
• Support the preparation of review materials, approval documentation, release records, and controlled project documentation.

Skills

Project coordination

Documentation management

Workflow administration

Stakeholder communication

Cross-functional collaboration

English fluency

Education

Bachelor's degree in Business Administration or related field

Tools

Windchill

Jira

Confluence

SharePoint

TMS

CCMS

Job description

Change people's lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives.

About the Role

We are seeking a highly organised and detail-oriented Regulatory Operations Project Coordinator to support Regulatory Operations, Content Development, Localisation, and related operational projects. This role is responsible for project coordination, workflow administration, documentation management, reporting, and system transaction support to ensure activities are completed accurately, consistently, and on time.

The successful candidate will work closely with internal and cross-functional teams and stakeholders, supporting multiple projects while maintaining high standards of organisation, communication, and process compliance.

Key Responsibilities

Project Administration & Coordination

• Maintain project schedules, action lists, trackers, and coordination records to support project delivery.
• Organise project information, prepare materials, and follow up on assigned actions with internal teams and stakeholders.
• Coordinate communications between teams, vendors, reviewers, approvers, and other stakeholders.
• Monitor and follow up on outstanding actions, reviews, approvals, and missing inputs, escalating where required.
• Support multiple projects and workstreams while ensuring priorities and deadlines remain visible and on track.

Workflow & System Administration

• Execute routine workflow and system transactions across tools such as Windchill (PLM), TMS, Jira, Confluence, SharePoint, and project tracking platforms.
• Process change requests, status updates, task routing, workflow records, and tracker updates in accordance with established procedures.
• Monitor workflow queues, approvals, tasks, and system activities to ensure timely completion.
• Maintain accurate and consistent records across both manual trackers and system-based workflows.
• Escalate workflow issues, missing information, unclear requests, or stalled activities to the appropriate stakeholders.

Project Tracking, Reporting & Documentation

• Maintain project trackers, dashboards, status reports, action logs, issue registers, and task lists using accurate and up-to-date information.
• Identify overdue activities, incomplete tasks, missing information, and recurring delays, ensuring they are highlighted to relevant owners.
• Prepare routine project status updates, including progress, upcoming milestones, risks, and open actions.
• Create, update, maintain, and manage project documentation, ensuring proper version control, storage, accuracy, and audit readiness.
• Support the preparation of review materials, approval documentation, release records, and controlled project documentation.

Stakeholder Support & Continuous Improvement

• Provide clear, professional, and timely communication on project activities, deadlines, actions, and workflow updates.
• Work collaboratively with cross-functional teams and stakeholders across different locations to gather information, resolve routine issues, and drive task completion.
• Support team by maintaining visibility of decisions, commitments, outstanding actions, and next steps.
• Ensure compliance with established processes, templates, workflows, and coordination standards.
• Identify process improvement opportunities, recurring workflow challenges, and administrative inefficiencies, and contribute to continuous improvement initiatives.

Requirements

• 1-3 years of experience in project coordination, administration, operations support, PMO support, document control, workflow management, change control, or similar structured business support roles.
• Strong organisational, planning, and multitasking skills with the ability to manage competing priorities.
• Excellent attention to detail, communication, and follow-up skills.
• Experience using business systems, workflow tools, collaboration platforms, spreadsheets, trackers, and document repositories.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Fluent in English (written and spoken).

Preferred Qualifications

• Experience supporting regulated, technical, documentation, localisation, project, or shared services environments.
• Exposure to global teams, Centres of Excellence (CoE), cross-functional projects, or high-volume operational workflows.
• Familiarity with Windchill, Jira, Confluence, SharePoint, TMS, CCMS, or similar enterprise systems.
• Degree in Business Administration, Project Coordination, Communications, or a related discipline. Equivalent work experience will also be considered.

Why Join Us?

• Opportunity to work with regional and global stakeholders in a collaborative environment.
• Gain exposure to Regulatory Operations, localisation, content development, workflow management, and enterprise systems.
• Contribute to operational excellence and continuous improvement initiatives while building valuable project coordination experience.

Apply Now

We welcome applicants who are proactive, organised, and passionate about delivering high-quality project and operational support. If you thrive in a structured environment and enjoy keeping projects on track, we encourage you to apply.