Project Manager

The Project Manager leads the project to obtain and maintain specific qualification for our China entity, not limited to Market Authorization Holder (MAH) qualification, overseeing all planning, coordination, and execution activities. The role ensures the project complies with local regulations and aligns with corporate quality and regulatory standards, and will coordinate cross-functional teams to ensure readiness, compliance, and project success in China.

Project Management & Execution:
• Lead and manage projects in accordance with company standards and processes.
• Develop and oversee project plans, timelines, milestones, and deliverables.
• Prepare and maintain project documentation (requirements, charters, business cases, planning/tracking docs).
• Assess project risks and critical paths; escalate issues to leadership as needed.
• Manage project budgets and financial evaluations. Define project team roles and responsibilities.

Stakeholder Engagement & Communication:
• Coordinate and align with internal and external stakeholders, including APAC teams.
• Interact directly with stakeholders and clients to address needs.
• Prepare and deliver professional, bilingual reports and presentations for senior leadership.
• Chair project meetings, coordinate calls and follow-ups, and attend meetings across time zones.

Quality, Compliance & Improvement:
• Ensure projects comply with local and applicable regulations and standards.
• Contribute to process improvements and best practices.
• Maintain accurate records, PMO data, and notes for all projects.
• Provide background research as required.

Administrative & Operational Support:
• Attend office/virtual meetings and phone calls
• Develop project-related documentation such as Meeting notes, Reports, Presentation, Financial reports, Project Charter, Business Case, Project Planning, Project road map, etc.
• Travel in and out of China as required.

1. Bachelor’s degree or higher in Regulatory Affairs, Biomedical Engineering, Quality Management, or related field
2. Experience in project management in a regulated manufacturing environment or process supply industry is essential
3. 8–10 years in medical device regulatory, quality, or project management roles in China; direct experience w/ MAH is highly preferred
4. Previous experience working within a quality management system essential
5. Solid understanding of NMPA device registration, MAH policy, ISO13485, and GMP requirements
6. Strong project management, communication (English & Chinese), problem-solving, and stakeholder coordination
7. Qualification in Project Management is highly desirable
8. Be able to work across multiple functions and cultures to ensure our results