You will be responsible for:
· Establishing and maintaining the good and closed relationship with SFDA testing centers. And successfully gains product registration certificates per registration forecast plan.
· Establishing and maintaining 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.
· Monitoring and reporting on local regulation changes and its impact together to company. Assists manager to handle daily work in Regulatory Dep.
· Working with sales and marketing dep. to fulfill product registration plan. Achieves RD expectation on product registration.
· Establishing and maintaining the good relationship with key contacts. Recommends valuable suggestion to company
· As a member of RD, providing active and strong regulatory supports to internal dep. as needed.
· Initiatively dealing with daily works. Keeps 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 have:
· Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry .
· 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
· Innovating with good independent working ability
· Energetic team spirit
· Medical Laboratory background preferred.
· Familiar with medical device regulation.
· Fluent English in listening, speaking and writte.
· Good skill on computer, MS-Office operation.
Regulatory Affairs、 Regulatory Affairs > General Regulatory Affairs
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