岗位职责

•Establish, maintain and execute appropriate registration plan on the responsible pipeline, based on project priority and lead time.
对所负责的产品线，根据项目优先程度和所需的时间，建立、维护并执行合适的产品注册计划。
•Forecast and maintain an appropriate registration project budget plan to the responsible pipeline.
对所负责的产品线，预测并维护合适的注册项目预算表。
•Take over the whole procedure of registration, including sample ordering, testing, dossier preparation, submission, uation and license obtaining.
负责产品注册的全过程，包括定样品、检测、资料准备、递交、审评和获取注册证。
oReview, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation.
对须提交的注册文件进行评估、编辑和校对。实时跟进注册文件的状态和进展情况。
oEnsure compliance with authority regulations and interpretations.
确保注册工作符合监管法规及相关解释。
oPrepare responses to authoritys questions and other correspondence.
就如何回复监管机构的问题及其它质询进行准备。
oGather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
收集并整理法规信息及相关指导意见以使注册申请能够符合要求。
oProvide solutions to a variety of problems of moderate scope and complexity.
为特定范围及复杂程度的各种问题提供解决方案。
oOrganize and maintain reporting schedules for new device application.
组织和确保对新设备申请的进度进行汇报。
oMaintain and renew of existing registrations.
现有注册的维护和更新。
oInvolved in related product inspections and coordinate with international teams to solve related issues.
负责产品检测并与国外同事协调解决检测中出现的问题。
•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.
为了使产品注册进程更顺利或对法规/指导原则的制定起到影响作用，相应地协调和组织公司及监管机构之间的研讨会，并贡献出有建设性的影响力。
•Assist in preparation and review of labeling, SOPs, and other departmental documents.
协助对标签、流程文件及其它部门文件进行准备及评估。
•Participate as an active team member of project teams as required.
必要时作为项目组成员参与工作。

任职要求

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.
本科以上学历，医学、制药、生物、工程、机械或相关专业
•More than 3 years regulatory affairs working experience with around 3 years focusing on medical device field
3年以上注册事务工作经验，3年左右医疗器械领域工作背景
•Familiar with imaging products, surgical products or IVD preferred
熟悉影像产品、外科产品或体外诊断试剂者优先
•Working in MNCs preferred
跨国企业工作背景优先
•Good communication and interpersonal skills
良好的沟通和人际交往技巧
•Strong attention to details, be very careful and responsible
注重细节，认真负责
•Problem solver, identifies problems and solves them proactively, be creative in thinking of nate solutions to problems.
问题解决者，积极发现问题并解决问题，会创造性的思考替代方案
•Fluent English (verbal and written forms)
流利的英文（口头及书面）

公司简介：
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.

我们是豪洛捷

豪洛捷公司（纳斯达克代码：HOLX）是一家领先同侪，集研发、制造和供应优质医疗影像系统、诊断和外科手术产品于一体的公司，以服务全球妇女医疗健康需求为己任。
豪洛捷公司致力于帮助全球各地妇女得以享受更健康、更长寿的生活。这就是豪洛捷存在之意义和唯一专注的焦点。我们追求的每次突破、设计的每个方案、和决定的每项投资都为迈向这目标。
我们为此自豪，同时也意识到作为行业领导者应有的道义。我们认为，当今妇女所面临的医疗健康问题值得并且需要一家充满激情和奉献精神的公司来服务。
我们的核心业务集中在乳腺健康、诊断产品、妇科和骨骼健康方面。