天津招聘

Business Segment
Healthcare China

About Us
What do you envision for your future? At http://www.gehealthcare.com target GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world.

We employ more than 52,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.

At GE, developing people is embedded in our culture and integral to our growth. Something remarkable happens when you bring together people who are committed to making a difference - they do!

At work for a healthier world.

Role Summary/Purpose
The Regulatory Affairs Leader provides subject matter expertise and works with a team of regulatory affairs professionals to ensure GEHC establishes best practice within the assigned area of responsibility (regional regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc).

Essential Responsibilities
Key responsibilities include:
1. Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility.
2. Identify regulatory trends and their implications for GE Healthcare; Develop & implement effective regulatory strategies to meet business objectives
3. Analyze & communicate proposed, new or changing requirements, & devise strategies for their implementation, ensuring business goals are met.
4. Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility.
5. Educate, train, & advise company professionals to ensure compliance with RA requirements.
6. Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety.
7. Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
8. Support continuous improvement activities with regard to areas of responsibility.
9. Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility.

Qualifications/Requirements
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
5. Effectively support implementation & management of current regulatory requirements within area of responsibility
6. Ensure assigned regulatory submissions are accurate, complete and timely

1. Bachelor’s Degree & minimum of 5 years experience in the medical device or pharmaceutical industry or government / government relations; OR minimum of 10 years progressive regulatory affairs experience in 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 environment
4. 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 manner
6. Prior experience using spreadsheet and presentation software
7. Must be willing to travel up to 15% of time.
Requirements:
1. Bachelor’s Degree & minimum of 5 years experience in the medical device or pharmaceutical industry or government / government relations; OR minimum of 10 years progressive regulatory affairs experience in 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 environment
4. 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 manner
6. Prior experience using spreadsheet and presentation software
7. Must be willing to travel up to 15% 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. 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.