Job Summary :
You will be responsible to establish and maintain the good and closed relationship with SFDA testing centers. And successfully gains product registration certificates per registration forecast plan. Establishes and maintains the good and closed relationship with hospital IVD departments (clinical Lab, drug monitoring lab, GCP, etc…). And builds up and represents Roche Diagnostics' good image, and gain products clinical trial reports per action plan. Monitors and reports on local regulation changes and its impact together to company. Assists manager to handle daily work in Regulatory Dept. .
Main Tasks & Responsibilities :
· Working with sales and marketing dept. to fulfill product registration plan. Achieving RD expectation on product registration.
· Establishing and maintaining the good relationship with key contacts. Recommending valuable suggestion to company.
· As a member of RD, provides active and strong regulatory supports to internal dep. as needed.
· Initiatively dealing with daily works. Keeping records. Has clear filing and maintain of all documents.
· Other projects or tasks assigned by line manager.
· Conducting business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
You should hold Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry.
· Have not less than 2 years about experience in medical regulatory affairs, focus on testing center and clinical trial. Understand IVD products' Standard like industry and national standards ( YY and GB).
· High enthusiasm and devotion, work hard and earnest.
· Willing to work under pressure, self-starting and self-inspiring.
· Be honest and open, excellent interpersonal communication skill, ability of social activity and collaboration.
· Who we are