Associate Project Manager, Regulatory Operations

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, an d continuous improvement initiatives . This is an excellent opportunity for professionals with experience in project coordination, operations, documentation management, regulatory support, or structured workflow environments who are looking to grow their project management capabilities.

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 escalate 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, handoff 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, a

Additional Information

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.

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