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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health.

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical Solutions and Medical Aesthetics is also what differentiates us — the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together we advocate for better health and wellness through solutions that provide even-greater certainty and peace of mind.

Regulatory Supervisor

Location: Beijing, Beijing Shi CN

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Job Number: 929

External Description:

Job Title: Regulatory Supervisor
注册主管
Division: RAQA
注册及质量管理
HR-Location: China
中国

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
豪洛捷是一家领先同侪,集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、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。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球妇女得以享受更健康、更长寿的生活。目前Hologic亟需优秀人才的加入。

Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信,人才是公司宝贵的财富,只有通过招聘、培训、发展、保留最优秀的人才,我们才能持续成功。

Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
我们的工作氛围是促进创新和以客户为中心。我们为员工提供最先进的工具和技术,合作和充满激情的工作环境,以提升世界各地的医疗保健水平。

We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
公司总部位于马萨诸塞州,在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
我们正在迅速成长,我们将更加关注员工、成长与未来。这是一个激动人心的历史时刻,可以访问我们的网站以了解更多的职业生涯的机会。

Hologic has China commercial organization with headquarter in Beijing. We aim to build the China Organization into an exciting place to work and grow professionally.
豪洛捷在中国设置了完整的商业机构,总部位于北京,我们致力于打造积极的、专业的商业运营机构。

Key Responsibilities include:
主要职责:
• Evaluate product registration strategy, cost, timeline, and registration risk based on acknowledged information to support business registration decision.
基于已知信息,评估产品注册方案、成本、时间、和注册风险,以支持业务部门的注册决策。
• 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, evaluation 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。
o Review, 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。
o Ensure compliance with authority regulations and interpretations.
确保注册工作符合监管法规及相关解释。
o Prepare responses to authority's 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。
o Gather 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。
o Provide 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。
o Organize 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。
o Maintain and renew of existing registrations.
现有注册的维护和更新。
o Involved 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。

Qualifications & Experience
经验/需求:

• 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 7 years regulatory affairs working experience with 5 years focusing on medical device field
7年以上注册事务工作经验,5年及以上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 background 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 alternate 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)

There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care. Hologic believes that people are the greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
欢迎您能和我们一起为人类健康努力工作,豪洛捷公司相信人力资源是公司的巨大财富,只有通过获取和维持努力工作的人力资源才能使公司获得成功。我们的工作氛围非常有刺激和创造力,并以客户为中心。我们为员工提供当前社会最新的技术、协作、热情的工作氛围,相信能为全球健康事业创造更好的未来!

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.
我们在中国正在快速增长,并更加专注于人才、增长和未来!

The Science of Sure.
科学成就未来!

 

Job Number: 929

Community / Marketing Title: Regulatory Supervisor

Location_formattedLocationLong: Beijing, Beijing Shi CN