羅氏促進多元化

、公gong平ping性xing和he包bao容rong性xing，代dai表biao我wo們men所suo服fu務wu的de社she區qu。在zai全quan球qiu範fan圍wei內nei處chu理li醫yi療liao保bao健jian問wen題ti時shi，多duo元yuan化hua是shi成cheng功gong的de關guan鍵jian因yin素su。我wo們men認ren為wei
，包bao容rong性xing是shi理li解jie人ren們men不bu同tong醫yi療liao保bao健jian需xu求qiu的de關guan鍵jian。我wo們men共gong同tong擁yong抱bao個ge性xing，共gong同tong抱bao持chi對dui卓zhuo越yue護hu理li的de熱re情qing。加jia入ru羅luo氏shi，每mei個ge聲sheng音yin都dou會hui得de到dao重zhong視shi。

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。我們的成功源於創新、求(qiu)知(zhi)和(he)多(duo)元(yuan)化(hua)
，也(ye)源(yuan)於(yu)我(wo)們(men)把(ba)相(xiang)互(hu)間(jian)的(de)差(cha)異(yi)作(zuo)為(wei)一(yi)種(zhong)優(you)勢(shi)。為(wei)了(le)革(ge)新(xin)醫(yi)療(liao)健(jian)康(kang)領(ling)域(yu)，羅(luo)氏(shi)設(she)定(ding)了(le)遠(yuan)大(da)的(de)計(ji)劃(hua)，堅(jian)持(chi)學(xue)習(xi)和(he)發(fa)展(zhan)，並(bing)不(bu)斷(duan)尋(xun)找(zhao)與(yu)之(zhi)誌(zhi)同(tong)道(dao)合(he)的(de)夥(huo)伴(ban)。

羅氏提供平等的職業發展機會。