Position Summary:

Provides regulatory support for diagnostic product development and commercial diagnostic products in China.
Coordinates CFDA local lab test, local clinical trial study and complex regulatory documents ensuring that submissions are timely and regulatory ives are met. Compiles all material required for submissions, license renewals.
Keeps informed of professional and global regulatory information. Works with governmental regulatory agencies and other third party accrediting bodies.
Researches scientific and regulatory information in order to write, edit, and review documents.

All About You

Responsibilities:

?Represents the RA function on assigned cross-functional project teams.
?Interprets and applies regulations by creating regulatory strategies for China markets.
?Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations.
?Prepares hardcopy and electronic information packages for submission to regulatory agencies.
?Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
?Reviews validation, clinical and stability protocols and reports for regulatory submission soundness.
?Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations.
?Defines, monitors and receives deliverables for submissions.
?Writes and/or edits submission documents using regulatory templates, or creates new templates.
?Assembles paper and/or electronic copies for submission.
?Monitors new and revised regulatory requirements disseminates information as directed by management.
?Interacts with regulatory agencies and third party accrediting bodies.
?Prepares internal procedures for continuous process improvement.
?Mentors junior members of the department.
?Provides regulatory guidance and/or training to external departments and partners.
?Assists with resource planning and budgeting as needed.

All listed tasks and responsibilities are deemed as essential functions to this position however, business conditions may require reasonable accommodations for additional task and responsibilities.

Requirements:

?5+ year experience in Regulatory Affairs.
?Experience with an in vitro diagnostics device multi-nation company required pharmaceutical, biologics or medical device companies as native.
?Strong understanding of CFDA regulations required other international requirements - EU, Canada, Australia, Japan and Korea - preferred.
?Demonstrated ability to work independently with new, complex technologies and produce professional work products.
?Strong written and verbal communication skills.
?Team leadership skills preferred.
?Familiarity and ability to work with office automation programs and corporate database tools.
?Strong work ethic and demonstrated ability to deliver assignments on time.

Education:

?Bachelor’s degree or equivalent in healthcare or diagnostics related field required.
?Additional coursework in regulatory or quality strongly desired.


Job Deion (工作說明)
崗位概述：

為在中國的診斷類產(chǎn)品開發(fā)和商用診斷類產(chǎn)品提供監(jiān)管支持。
協(xié)助中國國家食品藥品監(jiān)督管理局開展本地實(shí)驗(yàn)室檢測(cè)、本地臨床試驗(yàn)研究以及復(fù)雜的監(jiān)管文件資料工作，確保及時(shí)申報(bào)提交并達(dá)到監(jiān)管目標(biāo)。編制申報(bào)提交、許可更新所需的所有文件資料。
保持關(guān)注并獲知專業(yè)的和全面的監(jiān)管信息。與政府監(jiān)管機(jī)構(gòu)以及其他第三方認(rèn)證機(jī)構(gòu)合作。
研究學(xué)習(xí)科學(xué)知識(shí)和監(jiān)管信息，以便撰寫、編輯和審閱文件資料。

候選人要求

崗位職責(zé)：

?代表監(jiān)管事務(wù)(RA)職能部門，加入被分派的跨職能項(xiàng)目團(tuán)隊(duì)工作。
?解讀并運(yùn)用監(jiān)管法規(guī)，為中國市場(chǎng)制定監(jiān)管策略。
?為復(fù)雜項(xiàng)目制定并執(zhí)行監(jiān)管計(jì)劃，包括新產(chǎn)品項(xiàng)目以及為現(xiàn)有的銷售許可維護(hù)批件/執(zhí)照/許可證。
?編制向監(jiān)管機(jī)構(gòu)提交的文件資料的紙質(zhì)和電子信息包。
?為確保監(jiān)管合規(guī)，就標(biāo)簽、制造和分析及臨床研究計(jì)劃等方面的事宜提供建議。
?為確保所提交監(jiān)管文件資料的完善性，審閱各項(xiàng)驗(yàn)證、臨床和穩(wěn)定性方案和報(bào)告。
?通過變更控制評(píng)估制造流程和標(biāo)簽，確定對(duì)監(jiān)管報(bào)表影響和遵守法規(guī)情況；
?規(guī)定、監(jiān)督并接收用于申報(bào)提交的文件資料。
?使用監(jiān)管文件模板或創(chuàng)建新的模板，撰寫和/或編輯申報(bào)提交的文件資料。
?裝訂整理所提交文件資料的紙質(zhì)和/或電子副本。
?密切關(guān)注新的和修訂的監(jiān)管要求，按照管理層的指示發(fā)布相關(guān)信息。
?與監(jiān)管機(jī)構(gòu)及其他第三方認(rèn)證機(jī)構(gòu)溝通交流。
?編制內(nèi)部規(guī)程，實(shí)現(xiàn)流程持續(xù)改進(jìn)。
?指導(dǎo)本部門的初級(jí)員工。
?為其他部門及合作伙伴提供監(jiān)管指導(dǎo)和/或培訓(xùn)。
?根據(jù)需要，協(xié)助制定資源規(guī)劃和預(yù)算。

以上所列的任務(wù)和職責(zé)是本崗位的基本職能；工作開展中可能需要合理完成額外的任務(wù)和職責(zé)。

崗位要求：

?在監(jiān)管事務(wù)領(lǐng)域具有5年以上經(jīng)驗(yàn)；
?要求具有在體外診斷設(shè)備跨國公司工作的經(jīng)驗(yàn)，或具有在制藥、生物制品或醫(yī)療設(shè)備公司工作的經(jīng)驗(yàn)；
?要求深入理解中國國家食品藥品監(jiān)督管理局監(jiān)管法規(guī)，熟知?dú)W盟、加拿大、澳大利亞、日本和韓國等其他國家要求者優(yōu)先；
?具有良好的工作能力，能夠運(yùn)用新型復(fù)雜技術(shù)獨(dú)立工作并生成專業(yè)工作成果；
?優(yōu)秀的書面和口頭交流技能；
?具備領(lǐng)導(dǎo)力技能者優(yōu)先；
?熟練運(yùn)用辦公自動(dòng)化軟件及企業(yè)數(shù)據(jù)庫工具；
?具備優(yōu)秀的職業(yè)道德，切實(shí)能夠按時(shí)交付工作任務(wù)。

教育背景：

?要求具有醫(yī)療護(hù)理或診斷等相關(guān)領(lǐng)域本科學(xué)歷。
?亟需參加過監(jiān)管或質(zhì)量管理方面課程學(xué)習(xí)的人士。

Illumina是一家領(lǐng)先的生命科學(xué)工具和綜合系統(tǒng)開發(fā)、制造和營銷商，其產(chǎn)品主要用于大規(guī)模分析遺傳變異及其功能。這些系統(tǒng)讓在幾年前還不敢想象的研究得以順利開展，使我們更加靠近實(shí)現(xiàn)個(gè)性化醫(yī)療的目標(biāo)。隨著技術(shù)的飛速進(jìn)步，提供創(chuàng)新、靈活、可擴(kuò)展的解決方案和業(yè)內(nèi)領(lǐng)先的支持服務(wù)配套至關(guān)重要。
我們致力于通過強(qiáng)調(diào)互動(dòng)協(xié)作、快速交付解決方案、滿足客戶需求來面對(duì)這項(xiàng)挑戰(zhàn)。
我們的客戶廣泛分布于全球，涵蓋了學(xué)術(shù)組織、政府部門、制藥廠商、生物技術(shù)公司和其他領(lǐng)先的機(jī)構(gòu)。