北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医疗器械注册招聘

Associate RA Specialist

美敦力中国

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2020-03-18
  • 工作地点:北京
  • 招聘人数:1人
  • 工作经验:1年经验
  • 学历要求:本科
  • 职位类别:医疗器械注册

职位描述

MAIN JOB DUTIES/RESPONSIBILITIES:

- In co-ordination with Sales/Marketing Managers and Operation/Production Manager, implement effective product/plant registration approval strategies. Prepare and submit product registration and ensure approval for timely market release of new products.

-Serve as Medtronic’s representative for contacts with the state, provincial, and local branches of appropriate medical and health authorities such as SFDA, SMDA and other agencies as necessary for the approval of product/plant registration, clinical trials.

- Serve as Medtronic’s representative for organisations such as American Chamber of Commerce, U.S. Embassy’s Commercial Dept., in support of the industry and lobby government for reasonable and favourable regulations/legislations.

- Build and maintain close relationships with related government agencies and KOL’s, to establish Medtronic as an industry leader, and assist and lobby them in the formulation and implementation of fair regulations governing product approval. Monitor changes and feedback information regarding critical development in these regulations to his/her Manager.

- Monitor market activities such as competitor’s information.

- Provide regular submission and approval status of product registration to his/her Manager and the Business Managers.

- Inform headquarters’ SBU Regulatory Affairs staff of data necessary for inclusion in submissions. In cooperation with Product Development, Marketing and Sales organisations, search for ways to reduce the total costs and time from product development to market release.

- Monitor the country organisation’s compliance with the laws and regulations governing product/plant registration, and report impacts and probable actions to his/her Manager.

- Carry out product field corrective actions and related activities.

- Process, and provide regular reports on, product complaints and quality issues from the field according to the country’s regulations and the Company’s internal procedures to ensure compliance and satisfactory resolution of such complaints.

- Assist Sales and Marketing staff in sales and marketing activities.

- Other duties as directed.



Job Experience/Competency required:

- B.S. in biomedical, engineering, medical or other related majors. Specialty related to Medtronic product line is preferred.

- At least 2 years RA experience in medical device.

- Professional written and oral communication skills in English and Chinese.

- High scenes of work quality, looking into details.

- Well verse in Excel, Word and PowerPoint and general computer skills.

- Effective interpersonal communication skill

- Highly initiative and good team player

公司介绍

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

联系方式

  • 公司地址:北京