北京招聘

Business Segment
Healthcare Quality

About Us
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Role Summary/Purpose
The Regulatory Affairs (RA) Manager/Leader – Product provides subject matter expertise. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of premarket regulatory submissions and new product development.

Essential Responsibilities
• File / maintain regulatory deliverables • Actively participate as team member on all assigned new product introductions. • Create regulatory compliance / project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions; work with relevant personnel to ensure appropriate, timely input is provided for submissions. • Create and file submissions; communicate with authorities regarding these submissions. • If specific country testing is needed, work with Region RA, and arrange for test devices and support as needed. • Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products. • Review changes in existing products to determine need for new/revised submissions or document reason for no submission • Educate, train, & advise company professionals to ensure compliance with regulatory requirements • Communicate changes in existing products to Region RA representatives for determination of the need for new/revised licenses or registrations. • Partner with Region RA representative for countries with license expiration requirements, to establish plan and deliverables for timely submission for renewal of license. • Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan. • Provide RA oversight to clinical studies. • Support regulatory inspections as required. • Coach or mentor other RA professionals.

Qualifications/Requirements
1. Bachelor’s Degree (or internationally recognized equivalent) & minimum of 3 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration 2. Ability to prioritize, plan & evaluate deliverables to established strategic goals. 3. Proven application of analytical skills in a regulatory environment 4. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner. 5. Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research. 6. Strong problem solving and negotiation skills 7. Ability to work well independently & in a team setting. 8. Prior experience using spreadsheet and presentation software. 9. Must be willing to travel up to 10% of time.

Desired Characteristics
1. Advanced degree in scientific, technology or legal disciplines. 2. Regulatory Affairs Certification (RAPS). 3. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL. 4. Knowledge of Quality Management Systems (QMS) 5. Experience with working across cultures/countries/sites 6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. 7. 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.