Associate Project Manager, Regulatory Operations

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Exposure to global operations

Collaborative environment

Opportunities for professional growth

Job summary

C16 Cochlear Malaysia SDN BHD in Kuala Lumpur is seeking an Associate Project Manager dedicated to supporting regulatory and operational projects. The role involves managing project activities, coordinating workflows, and ensuring compliance with documentation standards.

The ideal candidate has 3–5 years of experience in project support, strong organisational skills, and excellent communication abilities. Join us to gain exposure to high-impact projects while collaborating with regional and global stakeholders.

Qualifications

• 3–5 years of experience in project management support or operational workflows.
• Strong ability to coordinate projects within governance frameworks.
• Excellent written and verbal communication skills in English.

Responsibilities

• Execute defined project activities and manage documentation workflows.
• Coordinate activities with stakeholders to ensure efficient project delivery.
• Maintain accurate project data and support audit readiness.

Skills

Project coordination

Organisational skills

Stakeholder management

Attention to detail

Cross-functional teamwork

Education

Bachelor's Degree in relevant field

Tools

Jira

Confluence

Windchill

SharePoint

Job description

About the Role

We are looking for a proactive and detail-oriented Associate Project Manager to support Regulatory, Content Development, Localisation, and related operational projects. In this role, you will be responsible for executing structured project activities, coordinating workflows, managing project documentation and system records, and ensuring work packages are delivered efficiently within agreed timelines. You will work closely with project teams, vendors, and stakeholders across global functions to support project delivery, data quality, compliance, and continuous improvement initiatives.

Key Responsibilities

• Project Planning & Execution Execute defined project activities and work packages within established project plans, timelines, and workflows. Convert project tasks into actionable plans by coordinating inputs, dependencies, deliverables, timelines and stakeholder responsibilities. Manage priorities, task sequencing, handoffs, and follow‑up activities across multiple projects and workstreams. Monitor progress, identify risks, delays, missing information, or resource constraints, and elevate issues when required.
• Workflow, Systems & Operational Delivery Manage project and documentation workflows across platforms such as Windchill, CCMS, TMS, Jira, Confluence, SharePoint, RIMS and other project management tools. Coordinate activities between Regulatory Operations, project teams, reviewers, vendors and global stakeholders to ensure efficient workflow execution. Maintain accurate project data, workflow records, documentation status and system information. Identify and resolve workflow challenges, unclear requirements, delays, and dependencies while ensuring compliance with established processes.
• Stakeholder Coordination & Reporting Coordinate with Project Managers, functional teams, reviewers, approvers, vendors and global stakeholders to support project delivery. Track actions, approvals, decisions, risks, issues and key deliverables to ensure project milestones are achieved. Prepare project reports, action registers, status updates, hand‑off documentation and decision records. Provide clear communication regarding priorities, deadlines, deliverables and project expectations while escalating unresolved issues when necessary.
• Documentation, Compliance & Quality Maintain accurate project documentation, trackers, reports, workflow records and document control processes. Ensure project outputs align with regulatory requirements, quality system expectations, submission strategies and business priorities. Review documentation and deliverables for completeness, accuracy, traceability and readiness before approval, submission or release. Manage impact of regulatory or business changes that may affect project scope, timing, deliverables or resourcing. Support audit readiness by maintaining appropriate records, approvals, decision logs and supporting documentation.
• Continuous Improvement & Capability Development Develop knowledge of Regulatory Operations, localisation, content development, project delivery and operational workflows. Identify process inefficiencies, recurring issues and workflow improvement opportunities, and contribute to process enhancement initiatives. Support the development of standard operating procedures, templates, checklists, training materials and scalable ways of working. Participate in process improvement, automation, reporting and system enhancement projects.

Requirements

• 3–5 years of experience in project coordination, project management support, operational workflows, documentation delivery, localisation, change control, submissions support or similar structured business environments.
• Proven ability to coordinate projects, workstreams, workflows or operational delivery activities within established governance frameworks.
• Strong organisational, planning, stakeholder management and follow‑up skills.
• Excellent attention to detail with the ability to manage multiple priorities and deadlines simultaneously.
• Experience using project management, workflow, document management and collaboration systems.
• Ability to work effectively with cross‑functional and global teams across different time zones.
• Comfortable managing ambiguity while maintaining structure, alignment and delivery focus.
• Strong written and verbal communication skills in English.

Preferred Qualifications

• Experience in regulatory submissions, technical documentation, labelling, localisation, quality systems or medical device environments.
• Familiarity with Windchill, CCMS, TMS, RIMS, Jira, Confluence, SharePoint or similar platforms.
• Exposure to regulated industries, product development, quality systems, operational reporting or controlled documentation environments.
• Experience supporting global teams, Centres of Excellence (CoE), shared services or cross‑functional project teams.
• Project management, operations, documentation control or change management training/certification is an advantage.

Education

Bachelor's Degree in Business, Communications, Science, Health Sciences, Engineering, Regulatory Affairs, Project Management or a related discipline. Equivalent education and relevant work experience will also be considered.

Why Join Us?

Work with regional and global stakeholders on high‑impact projects. Gain exposure to Regulatory Operations, localisation, technical documentation and structured project delivery. Build your project management expertise within a collaborative and fast‑paced environment. Contribute to process improvement, operational excellence and scalable business solutions.