南京招聘

Essential Responsibilities
1. Key contributor as part of a complaint handling unit 2. Clarify and drive timely investigation of adverse events by facilitating translation and communication.3 Coordinate inquiries from regulatory authorities. 4. Engaging product design owners to determine effective CAPA 5. Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)6. Reviewing appropriate criteria for closure of complaints 7. Owning and communicating metrics on status 8. Continuously working to improve the process
Role Summary/Purpose
This role combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling of incoming complaints. This role will facilitate communication, clarify, and drive the timely investigation of adverse events.
Qualifications/Requirements
1. Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 2 years work experience in a Quality or Regulatory Assurance related field
Desired Characteristics
1. Minimum 1 year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role

2. Productspecific knowledge

3. Demonstrated knowledge of 21CFR Part 820

4. Ability to demonstrate GEHC Growth Values

5. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment

6. Ability to work independently & in a team setting

7. Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English & Mandarin (and where appropriate, be able to communicate in the local language verbally and in writing).8. Excellent interpersonal, organizational, and influencing skills

9. Familiarity with the application of medical device as it relates to patient safety

10. Ability to analyze and process data, and draw the appropriate conclusions

11. Experience working with crossfunctional teams and facilitating teams to identify and implement solutions to complex problems

12. Ability to analyze and process data, and draw the appropriate conclusions

13. Experience working with crossfunctional teams and facilitating teams to identify and implement solutions to complex problems

14. Prior experience working with Microsoft Office products15. Working knowledge of GEHC products
About Us
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。