北京招聘

Business Segment

Healthcare China

About Us

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Role Summary/Purpose

The QARA Director is responsible for leading the overall Quality Assurance and Regulatory Affairs strategy and direction within the assigned area of responsibility (technical standards, laws and regulations, regulatory programs, etc) and geographic region. The QARA Director is expected to proactively build relationships and communicate with local regulators in their region of responsibility on regulatory-related issues, including pre-market and post-market.

Essential Responsibilities

• Communicate, build and maintaining strong relationships with regulatory authorities within areas of responsibility. The authorities typically include SFDA, local SFDA锛� MoH and CIQ, and as required local AIC or other departments • Lead and or contribute to deal with issues from post-market quality inspections within the region of responsibility • Lead and or contribute to the GEHC workshops with local regulators • Coordinate with local testing lab to monitor all assigned GE projects conducted in accordance with the target timeline and goals. • Work closely with other GEHC functions (GR, Legal) and senior local business leaders on overall government interaction strategy and emerging issue management. • Analyze & communicate proposed, new or changing requirements and standards, & lead teams to develop strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements • Educate, train, advise & coach company professionals to ensure compliance with QA and RA requirements. • Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility. • Lead & support continuous improvement activities with regard to areas of responsibility. • Recruit, mentor, coach and train direct and indirect reports on activities within area of responsibility

Qualifications/Requirements

1. Bachelor's Degree & minimum of 10 years experience in the medical device or pharmaceutical industry or medical productregulatory agencies; OR minimum of 14 years progressive regulatory affairs experience in medical device or pharmaceuticalindustry or medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulationsfor product registration, adverse event reporting, & recalls.2. Demonstrated ability to lead cross-functional, cross-business teams.3. Demonstrated knowledge of regulatory issues and significant experience interfacing with national and local regulatory bodies,including SFDA, local FDA and CIQ.4. Proven ability to analyze emerging technical or localized issues, develop plans to address, and communicate solutions withrelevant local government agencies.5. Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals.6. Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatoryenvironment7. Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiatingstrategies that demonstrate political awareness8. Ability to work well independently and in a team setting.9. Excellent verbal and written communication and presentation skills, tailoring communication methods to customer'srequirements.10. Ability to influence and make recommendations at all levels of the company11. Experience using spreadsheet and presentation software12. Must be willing to travel up to 15% of time

Desired Characteristics

1. Advanced degree in scientific, technology or legal disciplines.2. Knowledge of Quality Management Systems3. Experience working across cultures/countries/sites4. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast pacedenvironment.5. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change andmanage implementation effectively.6. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or politicalsituations and their impact on GEHC regulatory strategies.7. Previous work experience in related government agencies

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.