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羅氏促進多元化、公平性和包容性，代表我們所服務的社區。在全球范圍內處理醫療保健問題時，多元化是成功的關鍵因素。我們認為，包容性是理解人們不同醫療保健需求的關鍵。我們共同擁抱個性，共同抱持對卓越護理的熱情。加入羅氏，每個聲音都會得到重視。

職位

You will be responsible for:

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Establishing and maintaining the good and closed relationship with CFDA
testing centers. And successfully gains product registration certificates per
registration forecast plan.

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Establishing and maintaining the good and closed relationship with hospital
IVD departments (clinical Lab, drug monitoring lab, GCP, etc…). And building up
and represents Roche Diagnostics’ good image, and gain products clinical trial
reports per action plan.

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Monitoring and reporting on local regulation changes and its impact together
to company.

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Assisting manager to handle daily work in Regulatory Dep.

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Working with sales and marketing dep. to fulfill product registration plan.
Achieves RD expectation on product registration.

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Establishing and maintaining the good relationship with key contacts.
Recommends valuable suggestion to company

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As a member of RD, providing active and strong regulatory supports to internal
dep. as needed.

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Initiatively dealing with daily works, keeping records. Has clear filing and
maintain of all documents.

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Other projects or tasks assigned by line manager

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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:

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Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine
or biochemistry .

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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)

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Medical laboratory background.

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Familiar with medical device regulation.

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High enthusiasm and devotion, work hard and earnest

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Willing to work under pressure, self-starting and self-inspiring

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Be honest and open, excellent interpersonal communication skill, ability of
social activity and collaboration

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Innovating with good independent working ability

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Energetic team spirit

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Fluent English in listening, speaking and written.

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Good skill on computer, MS-Office operation.

我們是誰


在羅氏，來自100個國家的100，000名員工不斷推動著健康醫療行業的進步。我們一同工作，使羅氏成為了世界領先的以研發為基礎的健康醫療集團。我們的成功源于創新、求知和多元化，也源于我們把相互間的差異作為一種優勢。為了革新醫療健康領域，羅氏設定了遠大的計劃，堅持學習和發展，并不斷尋找與之志同道合的伙伴。

羅氏提供平等的職業發展機會。