苏州招聘

Description:

The Regulatory Affairs Specialist works with a team of regulatory affairs professionals to ensure GEHC establishes best practices within the assigned area of responsibility.

Key responsibilities/essential functions include:

· Support RA Director to collect the new national standards and regulations, and organize the commenting internally and consolidate the comments.

· Work closely with LS modality to handle the LS CFDA and SBTS submissions.

· Maintain the global Regulatory Intelligence database and global pre-market submission tracker.

· Support RA Director in documentation works for the CFDA partnership programs.

· Support RA Team to handle the logistics of internal and external activities including CFDA workshops, CFDA training programs, international meetings and team buildings.

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.

Required Qualifications:

1. Bachelor’s Degree (or international equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 2 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations

2. Strong analytical skills

3. Ability to work in a team environment with minimal supervision on projects and activities

4. Ability to prioritize, plan & evaluate deliverables

5. Knowledge & experience conducting scientific, regulatory, legal, or business research.

6. Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner

7. Experience using spreadsheet and presentation software

8. Must be willing to travel up to 5% of the time

Preferred Qualifications:

1. Advanced degree in scientific, technology or legal disciplines.

2. Regulatory Affairs and ISO13485 auditor Certification.

3. Experience in a medical device or pharmaceutical industry.

4. Knowledge of Quality Management Systems (QMS).

5. Experience working across cultures/countries/sites.

6. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

7. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

8. 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.