Regulatory Affairs Project Manager
Core
Lead regulatory projects for Abbott CRM product registration, approval, and lifecycle management in China.
Role type
Senior Regulatory Affairs Project Manager
Builds
Regulatory strategies and project execution for medical device product lifecycle
Domain
Medical Devices / Healthcare / China Regulatory Affairs
Required skills
Regulatory project management, China NMPA registration expertise, cross-functional stakeholder alignment, risk management, compliance documentation, multi-project prioritization
Preferred skills
CRM/Cardiovascular/Class III device experience, global matrix organization experience
Technologies
N/A
Responsibilities
Lead assigned regulatory projects and drive execution against timelines; Serve as China regulatory representative for cross-functional teams; Anticipate and manage regulatory risks and dependencies; Prepare and submit regulatory applications for product registrations and lifecycle activities; Coordinate testing, clinical evaluation, and submission documentation; Monitor China regulatory requirements and assess impacts
Seniority
Senior, hands-on IC