General Electric Senior Safety and Regulatory Engineer Leader in Wuxi, China
Job Description Summary
Senior 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 product safety 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. Give standards requirement inputs to critical components.
• Define TUV testing strategy and prepare test plan with TUV, support China Typing test, Safety and EMC testing, lead and support design meet standards.
• Work closely with regulatory, engineering, marketing, and other across team to get all target countries safety and regulatory requirements meet rigorously
• Screening new requirement, Awareness, Interpret (Impact Assessment), Implement & Compliance check, to assure the products compliance, and on time implement all new requirement.
• Support site regulatory inspections as required
• Collect & summarize performance metrics to identify program weaknesses & recommend improvements in procedures or oversight.
Lead and develop team capability for SRE area growth
Bachelor degree or above in Electrical, Mechanical, Computer Science or Biomedical Engineering and 8+ years of relevant design work experience. Minimum of 5 years’ experience with medical device design relative activities Proficient knowledge & experience in conducting design implementation for regulatory requirement Ability to prioritize, plan & evaluate deliverables Must be able to work effectively in a cross-functional team environment globally Strong communication skills, effectively in English (both written and oral) and a documented publication/patent record would be preferred
Strong working knowledge of Medical Device regulations, NMPA/FDA/MDD/MHLW.
Demonstrate knowledge for safety design.
Experience with IEC 60601 standard.
Demonstrated Program management skills.
Working knowledge of GEHC products and Quality Management Systems (QMS).
Self-starter, energizing, results oriented, and able to multi-task
Excellent interpersonal, organizational, communication and influencing skills.
Excellent teamwork, coordination and communication skills
Relocation Assistance Provided: No