崗位職責

?Establish, maintain and execute appropriate registration plan on the responsible pipeline, based on project priority and lead time.
對所負責的產品線，根據項目優先程度和所需的時間，建立、維護并執行合適的產品注冊計劃。
?Forecast and maintain an appropriate registration project budget plan to the responsible pipeline.
對所負責的產品線，預測并維護合適的注冊項目預算表。
?Take over the whole procedure of registration, including sample ordering, testing, dossier preparation, submission, uation and license obtaining.
負責產品注冊的全過程，包括定樣品、檢測、資料準備、遞交、審評和獲取注冊證。
oReview, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation.
對須提交的注冊文件進行評估、編輯和校對。實時跟進注冊文件的狀態和進展情況。
oEnsure compliance with authority regulations and interpretations.
確保注冊工作符合監管法規及相關解釋。
oPrepare responses to authoritys questions and other correspondence.
就如何回復監管機構的問題及其它質詢進行準備。
oGather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
收集并整理法規信息及相關指導意見以使注冊申請能夠符合要求。
oProvide solutions to a variety of problems of moderate scope and complexity.
為特定范圍及復雜程度的各種問題提供解決方案。
oOrganize and maintain reporting schedules for new device application.
組織和確保對新設備申請的進度進行匯報。
oMaintain and renew of existing registrations.
現有注冊的維護和更新。
oInvolved in related product inspections and coordinate with international teams to solve related issues.
負責產品檢測并與國外同事協調解決檢測中出現的問題。
?Coordinate and organize workshops between the company and authorities on the purpose of facilitating product registration or shaping regulation/technical guidance establishment, as well as contribute in constructive influence.
為了使產品注冊進程更順利或對法規/指導原則的制定起到影響作用，相應地協調和組織公司及監管機構之間的研討會，并貢獻出有建設性的影響力。
?Assist in preparation and review of labeling, SOPs, and other departmental documents.
協助對標簽、流程文件及其它部門文件進行準備及評估。
?Participate as an active team member of project teams as required.
必要時作為項目組成員參與工作。

任職要求

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
?Bachelor above degree majored in medical, pharmaceutical, biological, engineering, mechanical or related specialties.
本科以上學歷，醫學、制藥、生物、工程、機械或相關專業
?More than 3 years regulatory affairs working experience with around 3 years focusing on medical device field
3年以上注冊事務工作經驗，3年左右醫療器械領域工作背景
?Familiar with imaging products, surgical products or IVD preferred
熟悉影像產品、外科產品或體外診斷試劑者優先
?Working in MNCs preferred
跨國企業工作背景優先
?Good communication and interpersonal skills
良好的溝通和人際交往技巧
?Strong attention to details, be very careful and responsible
注重細節，認真負責
?Problem solver, identifies problems and solves them proactively, be creative in thinking of nate solutions to problems.
問題解決者，積極發現問題并解決問題，會創造性的思考替代方案
?Fluent English (verbal and written forms)
流利的英文（口頭及書面）

公司簡介：
We Are Hologic

Hologic, Inc. (Nasdaq: HOLX) is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world.


At Hologic, we are on a mission: to help women everywhere lead longer, healthier lives. It is our reason for being and the single focus of every breakthrough we pursue, every solution we design, every investment we make.
We are proud of our achievements and conscious of the responsibility that our leadership position brings with it. We believe that the health issues facing women today deserve and demand the singular dedication of a passionate company.
Our core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health.

我們是豪洛捷

豪洛捷公司（納斯達克代碼：HOLX）是一家領先同儕，集研發、制造和供應優質醫療影像系統、診斷和外科手術產品于一體的公司，以服務全球婦女醫療健康需求為己任。
豪洛捷公司致力于幫助全球各地婦女得以享受更健康、更長壽的生活。這就是豪洛捷存在之意義和唯一專注的焦點。我們追求的每次突破、設計的每個方案、和決定的每項投資都為邁向這目標。
我們為此自豪，同時也意識到作為行業領導者應有的道義。我們認為，當今婦女所面臨的醫療健康問題值得并且需要一家充滿激情和奉獻精神的公司來服務。
我們的核心業務集中在乳腺健康、診斷產品、婦科和骨骼健康方面。