Head of RA PDx, Greater China
Core
Provide regulatory strategy and direction for product launch, premarket submissions, and postmarket compliance in the healthcare industry.
Role type
Head of Regulatory Affairs (RA) / Second-line manager
Builds
Regulatory submissions and compliance frameworks for medical technology products
Domain
Healthcare / Medical Technology
Deliverable
client delivery
Required skills
Regulatory strategy, product launch management, post-market compliance, safety data management, functional leadership, policy development, stakeholder negotiation, budget management, complex problem solving
Preferred skills
Subject matter expertise in regulatory function, project management, talent development, cross-functional collaboration
Technologies
N/A
Responsibilities
Provide regulatory guidance for product launches and submissions; manage safety data and ensure compliance; lead functional teams and projects; influence policies and collaborate with internal/external stakeholders; provide business solutions to senior leadership
Seniority
Senior, hands-on IC with management responsibilities