Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Lead regulatory affairs function for Arthrex China.

Essential Duties and Responsibilities:

• Registration Strategy: Leads the formulation of registration strategies for products/projects. Ensures China registration strategies are appropriately designed and ensures effective implementation of the strategy. Ensures registration strategies adhere to corporate objectives and China business goals.
• Regulatory Knowledge: 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. Maintains awareness of industry & competitive knowledge and information.
• Agency Interactions: Acts as core point of contact to NMPA and relevant authorities/external organizations (test labs, CROs, NBs, etc) for products/projects. Liaises, negotiates and leads NMPA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor. Actively participates in the industry meetings and comments on regulations, guidance documents and standards.
• Dossier Submissions: Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across China and global Arthrex to obtain and/or provide information/data for regulatory submissions.
• Quality system: Responsible for managing an effective quality system.
• Team Interactions: Provides regulatory affairs representation on project teams and lead China RA teams. Acts as core point of RA contact on cross-functional teams and ensure the regulatory requirements are effectively communicated and strictly followed throughout the company.
• People Management: Lead and manage RA team.
• Plans and controls the annual budget for RA department.

Education and Experience:

• 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

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.