Lead regulatory affairs function for Arthrex China.
Leads the formulation of registration strategies for products/projects.
Maintains a high level of regulatory knowledge on global regulatory requirements (NMPA, FDA, EU, etc) and provides regulatory guidance for Arthrex China and global counterparts.
Acts as core point of contact to NMPA and relevant authorities/external organizations (test labs, CROs, NBs, etc) for products/projects.
Independently leads the preparation, coordination or monitoring of regulatory submissions.
Responsible for managing an effective quality system.
Provides regulatory affairs representation on project teams and lead China RA teams.
Plans and controls the annual budget for RA department.

Bachelor’s Degree required, preferably in a Science or Engineering discipline.
Minimum of 10 years’ experience in the position of regulatory affairs and quality domain, and 5 years’ experience in the RA/QA management role
Strong interpersonal and influencing skills as well as analytical/Statistical skills
Experience with working with cross-functional teams
Strong understanding of GMP requirements is an advantage.

Senior Regulatory Affairs Manager

Key skills