To get product compliance with NMPA and other agency regulation or policy and make sure the business operated in a safe environment. Coach and motivate the PMS team towards achieving the company’s goals.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The incumbent will also be responsible for, but not limiting to the following duties:
•Task with meeting monthly, quarterly and annual objectives and provide direction for the regulatory team to attain them
•Contact relative departments and manufacture to gain necessary files of products post market surveillance
•Establish and maintain the post market reporting Bowler
•Ensure staff skills are developed and maintained on a continual basis to ensure
•Ensure regulatory compliance in the organization , timely AE report and recall follow up.
•Good interface with government agency
•Adheres to policies and procedures
This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.
WORKING RELATIONSHIPS AND CONTACTS:
•External contacts for this position include NMPA, associations
•Internal contacts include headquarter, marketing team, logistic team, application and sales/ service team to gain support from them to resolve problem and make project forwarding.
SUPERVISION RECEIVED AND GIVEN:
The incumbent of this position is responsible for his/her team’s work. Only new work is reviewed before issue, all other work is handled independently, reporting status to Director. Some work requires analysis and use of initiative and independent judgment, but most assignments are specific and well defined.
EDUCATION & SKILLS:
•Bachelor degree of laboratory medicine, medical engineering, chemistry, biology and pharmaceutical or above is preferred.
•Excellent English skills in listening, speaking, reading and writing
•More than five years’ experience on similar position in this area.
This position also requires:
•Be experienced in regulatory field, be familiar with NMPA and international regulation of medical devices and/or IVD
•Excellent team work and interpersonal communication skill
•Good attitude, well habit of work, positive & take responsibility
•Analysis & Judgment
•Customer service oriented
This position may require business traveling in an ordinary situation.
This position functions in a general office environment.