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品開發和商用診斷類產品提供監管支持。
協助中國國家食品藥品監督管理局開展本地實驗室檢測、本地臨床試驗研究以及復雜的監管文件資料工作，確保及時申報提交并達到監管目標。編制申報提交、許可更新所需的所有文件資料。
保持關注并獲知專業的和全面的監管信息。與政府監管機構以及其他第三方認證機構合作。
研究學習科學知識和監管信息，以便撰寫、編輯和審閱文件資料。

候選人要求

崗位職責：

?代表監管事務(RA)職能部門，加入被分派的跨職能項目團隊工作。
?解讀并運用監管法規，為中國市場制定監管策略。
?為復雜項目制定并執行監管計劃，包括新產品項目以及為現有的銷售許可維護批件/執照/許可證。
?編制向監管機構提交的文件資料的紙質和電子信息包。
?為確保監管合規，就標簽、制造和分析及臨床研究計劃等方面的事宜提供建議。
?為確保所提交監管文件資料的完善性，審閱各項驗證、臨床和穩定性方案和報告。
?通過變更控制評估制造流程和標簽，確定對監管報表影響和遵守法規情況；
?規定、監督并接收用于申報提交的文件資料。
?使用監管文件模板或創建新的模板，撰寫和/或編輯申報提交的文件資料。
?裝訂整理所提交文件資料的紙質和/或電子副本。
?密切關注新的和修訂的監管要求，按照管理層的指示發布相關信息。
?與監管機構及其他第三方認證機構溝通交流。
?編制內部規程，實現流程持續改進。
?指導本部門的初級員工。
?為其他部門及合作伙伴提供監管指導和/或培訓。
?根據需要，協助制定資源規劃和預算。

以上所列的任務和職責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和職責。

崗位要求：

?在監管事務領域具有5年以上經驗；
?要求具有在體外診斷設備跨國公司工作的經驗，或具有在制藥、生物制品或醫療設備公司工作的經驗；
?要求深入理解中國國家食品藥品監督管理局監管法規，熟知歐盟、加拿大、澳大利亞、日本和韓國等其他國家要求者優先；
?具有良好的工作能力，能夠運用新型復雜技術獨立工作并生成專業工作成果；
?優秀的書面和口頭交流技能；
?具備領導力技能者優先；
?熟練運用辦公自動化軟件及企業數據庫工具；
?具備優秀的職業道德，切實能夠按時交付工作任務。

教育背景：

?要求具有醫療護理或診斷等相關領域本科學歷。
?亟需參加過監管或質量管理方面課程學習的人士。

Illumina是一家領先的生命科學工具和綜合系統開發、制造和營銷商，其產品主要用于大規模分析遺傳變異及其功能。這些系統讓在幾年前還不敢想象的研究得以順利開展，使我們更加靠近實現個性化醫療的目標。隨著技術的飛速進步，提供創新、靈活、可擴展的解決方案和業內領先的支持服務配套至關重要。
我們致力于通過強調互動協作、快速交付解決方案、滿足客戶需求來面對這項挑戰。
我們的客戶廣泛分布于全球，涵蓋了學術組織、政府部門、制藥廠商、生物技術公司和其他領先的機構。