Safety and Regulatory Engineer
- GE Healthcare
- Posted 7/26/2017 5:40:41 PM
- Job Function: Engineering/Technology
- Business Segment: Healthcare Ultrasound
Location(s): China; JiangSu; Wuxi
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
The Safety and Regulatory Engineer (SRE) role combines skills of Safety engineer and regulatory affairs (pre and post market), and will engage in product development teams to ensure safe and compliance. Also lead and drive new GEHC requirement, new standard/regulatory to implement in ultrasound devices on time.
• Engaging with NPI core teams to provide SRE deliverables such as Compliance Plan and design requirements, Technical Files etc.
• Typing test, Safety and EMC testing to meet standards.
• Work closely with regulatory, engineering, marketing, and other across team to get all target countries regulatory compliance, including 510k, MHLW, CFDA, CE etc.
• Screening new requirement, Awareness, Interpret (Impact Assessment), Implement & Compliance check, to assure the products compliance, and on time implement all new requirement.
• Support regulatory inspections as required
• Collect & summarize performance metrics to identify program weaknesses & recommend improvements in procedures or oversight.
1. Bachelor degree or above in electrical, or software product development
2. Ability to prioritize, plan & evaluate deliverables
3. Knowledge & experience conducting design, regulatory.
1. Strong working knowledge of Medical Device regulations, CFDA/FDA/MDD/MHLW.
2. Experience with IEC 60601 standard.
3. Demonstrated Program management skills.
4. Working knowledge of GEHC products
5. Excellent interpersonal, organizational, communication and influencing skills.
6. Excellent team-player skills w/global mindset.
7. Experience in a medical device or pharmaceutical industry.
8. Knowledge of Quality Management Systems (QMS).
Locations: China; JiangSu; Wuxi