天津招聘

Business Segment
Healthcare China

About Us
X

Role Summary/Purpose
The Regulatory Affairs expert provides subject matter expertise and works with a team of experienced regulatory affairs professionals and business partners to ensure GEHC China continue to perform with high standard in management of post market related issues including AER and recall reporting.

Essential Responsibilities
• Work closely with regulatory, field engineers, commercial, marketing, legal, and other professionals across the company to develop & implement the processes for post market issue management. • Review customer complaints and conduct the reportability assessment and AER reporting per China regulations • Independently lead the AER and recall reporting process by working with multi-deciplined team. • Identify regulatory trends and understand their implications to GE Healthcare; able to develop & implement effective regulatory strategies to meet business objectives • Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility, particularly on the post market issues management • Educate, train, & advise company professionals to ensure compliance with RA requirements. • Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight. • Drive improvements to overall post market Management System through programs and CAPA process.

Qualifications/Requirements
1. Bachelor’s Degree & minimum of 5 years experience in the medical device or pharmaceutical industry or government / government relations; including knowledge & experience applying global drug or device laws & regulations for product registration, adverse event reporting, & recalls. 2. Ability to prioritize, plan & evaluate deliverables to established strategic goals.3. Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment4. Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.5. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner6. Prior experience using spreadsheet and presentation software7. Must be willing to travel up to 15% of time.8. Must be willing to work out of normal hours to compensate global team schedule.

Desired Characteristics
1. Advanced degree in clinical medicine, technology or legal disciplines.2. Regulatory Affairs Certification (RAPS).3. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, CFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL. 4. Knowledge of Quality Management Systems (QMS)5. Ability to work across cultures/countries/sites 6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.7. Strong problem solving and negotiation skills 8. Ability to work well independently & in a team setting. 9. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

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.