Regulatory Support Associate
艾尔建信息咨询（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程 医疗设备/器械
职位信息
- 发布日期：2013-07-11
- 工作地点：上海
- 招聘人数：1
- 学历要求：本科
- 职位类别：医疗器械注册 其他
职位描述
KEY DUTIES AND RESPONSIBILITIES
Post Marketing Surveillance (PMS):
1. Establish the Product Complaint handling process for China.
2. Train and lead the key stakeholders involved in the Product Complaint handling process.
3. Report all Product Complaints to Product Surveillance Group in Santa Barbara.
4. Follow up closely on all the complaints and any associated explant returns, ensuring each complaint is closed.
5. Develop regular trending reports of product complaints from China.
6. Work closely with PV with regards to reportability to SFDA
7. Work closely with Global Product Surveillance Group, Regional Regulatory Support and China local RA operations to ensure that the process is running smoothly
Other Regulatory Support function:
1. Assist local RA in regulatory affairs matter
JOB REQUIREMENTS
Education and Experience:
1. 2-4 years experience in Medical device QA function
2. Understand and experience in working with in accordance to SFDA regulation.
Essential Skills and Abilities:
1. Good working knowledge and working relationship with SFDA.
2. Familiar with and adapt in working in a matrix organization.
3. Strong communication skills with supervisors, colleagues, peers and external parties including good written and spoken English.
4. Strong interpersonal skills and proven track record in working effectively with commercial teams.
5. Ability to develop and maintain strong relationships both internally and externally.
6. Result oriented ability to work in a fast paced environment.
7. Commitment to meet the needs of key stake holders covering corporate, regional and country management.
8. Ability to multi-task, prioritize and work under pressure.
9. Good organization skills and ability to work independently without close supervision.
10. Good attention to detail and accuracy.
11. Analytical problem solving.
12. Excellent verbal and written communication skills, diplomatic during difficult conversions with external parties.
13. Strong general computer literacy with Intermediate skills in Microsoft Word, Excel and Outlook.
14. Good organization skills and ability to work independently without close supervision.
15. Good attention to detail and accuracy.
16. Analytical problem solving.
17. Excellent verbal and written communication skills, diplomatic during difficult conversions with external parties.
Post Marketing Surveillance (PMS):
1. Establish the Product Complaint handling process for China.
2. Train and lead the key stakeholders involved in the Product Complaint handling process.
3. Report all Product Complaints to Product Surveillance Group in Santa Barbara.
4. Follow up closely on all the complaints and any associated explant returns, ensuring each complaint is closed.
5. Develop regular trending reports of product complaints from China.
6. Work closely with PV with regards to reportability to SFDA
7. Work closely with Global Product Surveillance Group, Regional Regulatory Support and China local RA operations to ensure that the process is running smoothly
Other Regulatory Support function:
1. Assist local RA in regulatory affairs matter
JOB REQUIREMENTS
Education and Experience:
1. 2-4 years experience in Medical device QA function
2. Understand and experience in working with in accordance to SFDA regulation.
Essential Skills and Abilities:
1. Good working knowledge and working relationship with SFDA.
2. Familiar with and adapt in working in a matrix organization.
3. Strong communication skills with supervisors, colleagues, peers and external parties including good written and spoken English.
4. Strong interpersonal skills and proven track record in working effectively with commercial teams.
5. Ability to develop and maintain strong relationships both internally and externally.
6. Result oriented ability to work in a fast paced environment.
7. Commitment to meet the needs of key stake holders covering corporate, regional and country management.
8. Ability to multi-task, prioritize and work under pressure.
9. Good organization skills and ability to work independently without close supervision.
10. Good attention to detail and accuracy.
11. Analytical problem solving.
12. Excellent verbal and written communication skills, diplomatic during difficult conversions with external parties.
13. Strong general computer literacy with Intermediate skills in Microsoft Word, Excel and Outlook.
14. Good organization skills and ability to work independently without close supervision.
15. Good attention to detail and accuracy.
16. Analytical problem solving.
17. Excellent verbal and written communication skills, diplomatic during difficult conversions with external parties.
公司介绍
艾尔建公司（纽约证券交易所：AGN），是一家总部位于爱尔兰都柏林的全球制药公司。同时也是一家勇往直前，引领全球制药行业的全新典范的增长型制药公司。艾尔建致力于研发、生产和销售品牌药品、医疗器械以及生物制剂等，以提高患者的生活质量。
艾尔建公司的品牌药产品覆盖了中枢神经系统，眼部治疗，医疗美容，消化，妇科，泌尿和抗感染等领域。
“开放科学”作为公司的研发模式，决定了我们探索、拓展并颠覆传统的想法，以创新的治疗方案不断提高患者的生活质量。艾尔建拥有的研发产品线，包括超过65个中后期阶段的在研产品线项目。
公司的成功有赖于全球16,000位艾尔建员工。我们勇往直前，创造生命无限潜能为使命，并倡导积极沟通、大胆创新、快速行动，结果导向，坚持正确的道路大胆前行。
艾尔建公司的业务遍布全球近100个国家和地区，并致力于和医生、医疗行业人士共同为患者提供创新而有效的治疗方案，帮助全球患者创造生命无限潜能，健康生活。
更多信息，请浏览
艾尔建中国官方网站：www.allergan.com.cn
艾尔建全球官方网站：www.allergan.com.
艾尔建公司的品牌药产品覆盖了中枢神经系统，眼部治疗，医疗美容，消化，妇科，泌尿和抗感染等领域。
“开放科学”作为公司的研发模式，决定了我们探索、拓展并颠覆传统的想法，以创新的治疗方案不断提高患者的生活质量。艾尔建拥有的研发产品线，包括超过65个中后期阶段的在研产品线项目。
公司的成功有赖于全球16,000位艾尔建员工。我们勇往直前，创造生命无限潜能为使命，并倡导积极沟通、大胆创新、快速行动，结果导向，坚持正确的道路大胆前行。
艾尔建公司的业务遍布全球近100个国家和地区，并致力于和医生、医疗行业人士共同为患者提供创新而有效的治疗方案，帮助全球患者创造生命无限潜能，健康生活。
更多信息，请浏览
艾尔建中国官方网站：www.allergan.com.cn
艾尔建全球官方网站：www.allergan.com.
联系方式
- Email：Sarah.Liu@Allergan.com
- 公司地址：上班地址：重庆市