天津招聘

Business Segment
Healthcare Medical Diagnostics

About Us
X

Role Summary/Purpose

Essential Responsibilities
•In all activities, to work closely with the regional RA manager. •To ensure regulatory compliance for Medical Diagnostics products in the relevant market •To strive that local RA activities reflect and support both local commercial and global business priorities •To drive the development and strengthening of MDX relationships with regulatory authorities and to act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions. •To provide proactive regulatory advice and expertise to other groups •To manage the local regulatory activities including; o Support to central RA for registration and clinical trials, o Support to local commercial on strategic and operational issues (promotional material, etc) o Support to central Pharmacovigilance for safety issues and adverse event reporting and to be the local responsible person for Pharmacovigilance, as appropriate to the role o In cases where there are direct line reports to this position - To manage the recruitment, development, training and activities of internal RA personnel, contractors and consultants. To direct and manage this resource as required to support GE Healthcare business needs. o To manage the RA budget for market(s) concerned. •To actively seek to represent GE HC’s regulatory function outside the company (local congresses and trade association meetings, etc.) •To ensure consistent and quality regulatory practices and procedures which are in line with the rest of NRA and meet the needs of CRA •To continuously review and put strategies in place to improve existing processes and champion change

Qualifications/Requirements
1.Bachelor’s Degree in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy 2.Strong analytical skills3.Ability to work with minimal supervision on projects and activities4.Ability to prioritize, plan & evaluate deliverables5.Knowledge & experience conducting scientific, regulatory, legal, or business research.6.Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner7.Prior experience using spreadsheet and presentation software8.Experience in regulatory regulatory affairs, and preferably, some experience of negotiating directly with local regulatory authorities.

Desired Characteristics

通用电气（GE) 公司是一家全球领先的科技、服务和金融公司，是全球最大的多元化企业，致力于解决世界上最棘手的问题。GE的产品和服务范围广阔，从能源、石油天然气、水处理、航空、医疗、运输系统、家电、照明，到金融，客户遍及全球100多个国家，拥有30多万员工。杰夫?伊梅尔特先生是现任董事长及首席执行官。

GE公司的历史可追溯到托马斯?爱迪生，他于1878年创立了爱迪生电灯公司。1892年，爱迪生通用电气公司和汤姆森－休斯顿电气公司合并，成立了通用电气公司（GE）。GE是道 琼斯工业指数1896年设立以来唯一至今仍在指数榜上的公司。

2011年GE的年销售达1420亿美元。

GE现有6个产业部门，其中包括：航空、交通运输、医疗、能源、GE金融、家庭和商业解决方案。

GE (NYSE: GE) is Imagination at Work – an advanced global technology, service and finance company that is taking on the world’s toughest challenge. Widely recognized as the world’s largest multi-business company, GE excels in a variety of sectors including energy, oil and gas, water treatment, aviation, healthcare, transportation, lighting, appliances and finance. GE serves customers in more than 100 countries and employs more than 300,000 people worldwide. Jeffrey R. Immelt is Chairman of the Board and Chief Executive Officer of GE.

The company traces its beginnings to Thomas A. Edison, who established Edison Electric Light Company in 1878. In 1892, a merger of Edison General Electric Company and Thomson-Houston Electric Company created General Electric Company. GE is the only company listed in the Dow Jones Industrial Index today that was also included in the original index in 1896.

Total revenue of GE reached $142.0 billion in 2011.

GE is having six businesses including: Aviation, Transportation, Healthcare, Energy, GE Capital, Home and Business Solutions.