天津招聘

Business Segment

Healthcare Quality

About Us

We are a $17 billion unit of General Electric Company (NYSE: GE), employing more than 46,000 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.

Role Summary/Purpose

The Regulatory Affairs Leader - Region may be involved in Pre or Postmarket duties or both. He/she provides subject matter expertise and works with a team of RA professionals to ensure GEHC establishes best practices in premarket & postmarket for RA, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.

Essential Responsibilities

• File / Maintain regulatory deliverables • Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies • Support local regulatory authority / notified body inspections as required • Educate, train, & advise company professionals to ensure compliance with regulatory requirements • Coach and mentor other RA professionals Premarket • Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions • Communicate with Product RA resources to establish regulatory requirements, including clinical trial data. • Provide RA support as needed to clinical studies to ensure regulatory requirements are met. • Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required. • Act as liaison with external regulatory reviewers to gain rapid approval of submissions. • Work with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license. • Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes. Postmarket • Reviews new reportable adverse events for country reportability. repare Recall submissions, localize if applicable. repare Regulatory Authority responses to inquiries; work with the P&L to ensure accurate response. ollowing PSRB decision, review field action information to determine if reportable in local country. upport regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes. ct as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports. rovide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L. • Monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner. 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.

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, adverse event reporting, & recalls 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. 10. Bilingual in Mandarin and English

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. 8. Experience with adverse event reporting and recalls.

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.