上海招聘

JOB SUMMARY/PURPOSE OF THE JOB:
The Sr. RA Specialist writes, files, and obtains approvals for domestic regulatory submissions. The Sr. RA Specialist defines the regulatory strategy for assigned projects and is a primary liaison with regulatory bodies to gain product licenses/registrations and business licenses. The Sr. RA assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements. The Sr. RA is the primary link between the HQ in Denmark (Tove) and the agencies used in China.

JOB SPECIFIC RESPONSIBILITIES:
Build direct relationship with CFDA
Build expertise and capability in medical information translation. May utilize subject matter expert consultant(s) to reduce license application preparation time.
Draft and update Chinese product standard according to product specification and China GB Standard
Prepare Chinese package insert
Translations
1.510K & PMA with summary report
2.Manufacture ISO, CE, CFG etc.,
3.Clinical study report (for new registration brand)
4.Technical documents
Prepare letters:Declaration letters, Guarantee letters, Authorization Letters, etc
Submit samples for China Test Lab testing and follow up
Submit regulatory documents to CFDA for product approval, and follow up on the status of approvals/renewals
Answer technical questions from CFDA and China Test Lab
Resolve discrepancies between labeling and original filings
Explain discrepancies between CFDA website and application
Company name changes
Brand Names/Device Listing
510(k) Summaries
Problem solving when test results don’t meet specification

JOB REQUIREMENTS:

1.Strong project management and technical writing skills
2.Effective communicator; able to convey messages in a logical and concise manner. Consistently reinforces regulatory expectations and requirements.
3.Bilingual Chinese – English. Oral and written.
4.Exceptional attention to detail with strong organizational skills.
5.Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities.
6.Able to work effectively in multinational/multicultural environments.
7.Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
8.Complies with all company policies and procedures.
9.Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
10.Conducts self in a professional manner with coworkers, management, customers, and others. Models the corporate values.
11.Has experience with adverse event reporting and is familiar with post-market surveillance and vigilance requirements.
12.Strong mathematical, analytical, and computer skills.
13.Strong working knowledge of domestic and international regulations.

澳励晶贸易（上海）有限公司成立于2008年，由澳励晶（ORIGIO）集团和上海同科博越医疗设备有限公司共同出资组成，专业为中国的辅助生殖技术（ART）提供最好的产品和服务。澳励晶集团旗下包括MEDICULT试剂（丹麦），HUMAGEN显微注射针（美国），MIDATALANTIC设备（美国），三家著名的生殖医学产品公司以及SCANLAB（生命科学专用超净工作台，离心机，丹麦）和MDT（生殖医学专用取卵针，移植管等，荷兰）二家合资工厂。

公司于2009年推出专业为试管婴儿培养设计的BT-37桌面培养箱；2010年推出了玻璃化冷冻解冻适合中国国情的改良套装（可以为中心和病人节省50%的费用）以及最新的CRYOPETTE封闭载体系统；2011年公司推出了首个用于流产妇女进行试管培养而无需用药的培养液EMBRYOGEN（安宝静），临床验证表明，持续着床率提高44%。使用简单———受精，三天培养，移植均用此液，适用于任何试管婴儿实验室系统。

公司近日引进美国最先进的环保技术，研发并由善缘科技生产“神奇之水”系列产品，现已问世。