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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.

RA Specialist

Location: Beijing, Beijing Shi CN

Notice

This position is no longer open.

Job Number: 857

External Description:

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 and Medical Aesthetics Solutions 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 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 ever greater certainty and peace of mind.

 

We are seeking a RA Specialist who is passionate about the field of imaging devices and is committed to grow with the company as we take on new emerging markets.

 

Primary Responsibilities

  • Establish, maintain and execute appropriate registration plan on the responsible pipeline, based on project priority and lead time
  • Forecast and maintain an appropriate registration project budget plan to the responsible pipeline
  • Take over the whole procedure of registration, including sample ordering, testing, dossier preparation, submission, evaluation and license obtaining
  • Review, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation
  • Ensure compliance with authority regulations and interpretations
  • Prepare responses to authority's questions and other correspondence
  • Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
  • Provide solutions to a variety of problems of moderate scope and complexity
  • Organize and maintain reporting schedules for new device application
  • Maintain and renew of existing registrations
  • Involved in related product inspections and coordinate with international teams to solve related issues
  • 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
  • Assist in preparation and review of labeling, SOPs, and other departmental documents.
  • Participate as an active team member of project teams as requiredTo 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.  
  • Qualifications & Experience:
  • Bachelor’s degree majored in medical, pharmaceutical, biological, engineering, mechanical or related specialties           
  • 7+ years’ regulatory affairs working experience with 3+ years’ focusing on medical device field
  • Familiar with imaging products, surgical products or IVD
  • Previous work experience within a multinational and cross matrix environment
  • Good communication and interpersonal skills
  • Strong attention to details, be very careful and responsible
  • Problem solver, identifies problems and solves them proactively, be creative in thinking of alternate solutions to problems
  • Effectively bilingual

岗位要求  

  • 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
  • 对所负责的产品线,预测并维护合适的注册项目预算表
  • 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
  • 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
  • 确保注册工作符合监管法规及相关解释
  • 就如何回复监管机构的问题及其它质询进行准备
  • 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
  • 为特定范围及复杂程度的各种问题提供解决方案
  • 组织和确保对新设备申请的进度进行汇报
  • 现有注册的维护和更新
  • 负责产品检测并与国外同事协调解决检测中出现的问题
  • 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
  • 协助对标签、流程文件及其它部门文件进行准备及评估
  • 必要时作为项目组成员参与工作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.
  • 资历要求
  • 本科以上学历,医学、制药、生物、工程、机械或相关专业
  • 7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
  • 熟悉影像产品、外科产品或体外诊断试剂者优先
  • 跨国企业工作背景优先
  • 良好的沟通和人际交往技巧
  • 注重细节,认真负责
  • 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
  • 流利的英文(口头及书面)

Job Number: 857

Community / Marketing Title: RA Specialist

Location_formattedLocationLong: Beijing, Beijing Shi CN