About this role
The Opportunity
The Regulatory Affairs Project Manager is responsible for leading assigned regulatory projects supporting registration, approval, and lifecycle management of Abbott CRM products in China.
The individual will work independently with cross-functional teams and global stakeholders to execute regulatory strategies, manage complex registration projects, and ensure compliance with applicable China regulatory requirements.
This role requires strong regulatory expertise, project management capability, and the ability to manage multiple priorities across an evolving product portfolio.
What You'll Work On
Project Leadership and Cross-Functional Collaboration
- Lead assigned regulatory projects and drive execution against agreed timelines, milestones, and business objectives.
- Serve as the China regulatory representative for cross-functional project teams, ensuring effective stakeholder alignment and decision-making.
- Anticipate and manage regulatory risks, issues, and dependencies to support successful project outcomes.
- Provide regulatory direction and influence project strategies throughout the product lifecycle.
- Monitor relevant China regulatory requirements, standards, and guidance updates. Assess regulatory impacts and support implementation activities where applicable.
Registration & Lifecycle Management
- Prepare and submit regulatory applications for product registrations, renewals, amendments, and other lifecycle management activities.
- Coordinate testing, clinical evaluation, standards compliance, and submission documentation activities.
- Assess and support implementation of product, software, manufacturing, labeling, and supplier changes.
- Ensure regulatory documentation complies with applicable regulations and company procedures.
Required Qualifications
- Bachelor's degree or above.
- 5+ years of Regulatory Affairs experience within medical devices or healthcare industries.
- Experience supporting China medical device registrations and lifecycle management.
- Knowledge of China medical device regulations and NMPA registration requirements.
- Experience managing multiple regulatory projects independently.
- Strong project management, communication, and stakeholder management skills.
- Strong quality compliance ethos.
- Can travel 10-15% of business time
- Fluent in English and Chinese.
Preferred Qualifications
- CRM, cardiovascular, active implantable, or Class III medical device experience.
- Experience working in a global matrix organization.