苏州招聘

Job objective
Product registration at SFDA, application CE mark certificate from notified body, and application for hygienic permission at MOH for disinfection manufacturer and disinfection product.
Regular duties and responsibilities
1. Product registration. Plan and arrange product type test with JSMIT, contact and ensure quality management system audit by SFDA, prepare and submit registration related documentation to SFDA and ensure registration certified in time.
2. Product CE Mark. Build quality management system according MDD and ensure compliance. Plan product test and quality system audit with notified body and ensure product certified in planned time.
3. Product registration in emerging markets.
4. Hygienic permission. Ensure production and products' complaince with laws and regulations on disinfection products. Plan and arrange product disinfection test with certified test body, apply and renew manufactuer hygienic permission license and disinfection product hygienic permission letter from MOH.
5. RoHS. Act on RoHS project, build and maintain SOP for RoHS and ensure RoHS compaliance with effective team work.
6. Attend internal audit. Lead or support maintenance of SOPs and instructions related to product certification, CE mark, and hygienic permission. Ensure RA documentation retention.
7. Other work assigned by QA / RA manager.
Authority
1. Decision on documentation to be submitted externally qualified or not.
2. External communication for regulatory affairs.
3. Internal cross-functional team work on regulatory affairs.
Qualification
Education
University degree in Mechanical Engineering, Electrical Engineering or equivalent
Training
Received the training about production operation and product knowledge
Experience
5 ~ 10 years of solid experience with multinational companies and being involved in aspects of product registration and quality assurance.
Skill
Background in medical device
Familiar with ISO13485, MDD and ISO14001, preferably certified auditor
Excellent communication skill and cooperation
Good command of English and Mandarin
Attitude
Self-motivated, team player, and able to work independently under pressure
A passion for regulation affair
Teamwork spirit.

洁定集团是总部位于瑞典的上市集团公司，洁定感染控制业务(GETINGE)是其三大业务领域之一。 洁定感染控制业务由卫生保健和生命科学两部分组成。 加上延伸护理业务（ARJO HUNTLEIGH）和医疗器械业务（MAQUET），洁定集团公司关注最先进的医疗技术。 截至2009年底，洁定集团销售总额达到230亿瑞典克郎,共有约12100名员工，其中中国大陆大约有600名员工。

在全球卫生保健和生命科学领域内，洁定感染控制业务处于消毒器和灭菌器供应商的领先地位。 自100多年前成立至今，洁定感染控制业务制作成为了消毒灭菌领域改革创新和科技进步的象征。 洁定感染控制业务分为三大客户部门。

- 卫生保健
- 药物/医疗器械
- 调研

洁定感染控制业务机构遍布全球，在六大洲有29个子公司、230多个经销商和代表洁定感染控制的销售、服务合作公司。


Getinge Infection Control (GETINGE) is one of the three business areas within GETINGE AB, a publicly-listed, Swedish-based group of companies. The Getinge Infection Control business area consists of two divisions: Healthcare and Life Sciences. Together with the two other business areas, Extended Care (ARJOHUNTLEIGH) and Medical Systems (MAQUET), the entire GETINGE group of companies focuses on state-of-the-art medical technology. For the fiscal year 2009, the GETINGE Group posted sales revenues of 23 billion SEK with a workforce of approximately 12,100 employees with approximately 400 of these employees in Mainland China.

Worldwide, Getinge Infection Control ranks among the leading providers of disinfectors and sterilizers within the healthcare and life sciences segments. Since its foundation more than 100 years ago, Getinge Infection Control has stood for innovation and technological progress in the field of disinfection and sterilization. Getinge Infection Control has three customer segments:

- Healthcare
- Pharmaceutical/Medical device
- Research

The Getinge Infection Control organization is to be found all over the world, with 29 subsidiaries on six continents and over 230 distributors and partner companies in sales and service representing Getinge Infection Control.