招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
语言要求:
英语
JOB TITLE: Engineer, RA
JOB GRADE:
SUMMARY:
For RA, develops and implements strategies for the timely approval of regulatory applications. Achieve required assigned division or product line regulatory registrations and certifications for products manufactured and sold. Assure compliance to the policies of worldwide regulatory agencies by establishing procedures for division or product as required.
DUTIES:
RA:
Develops and implements strategies for the timely approval of regulatory applications. Provide timely updates to management on changes in regulatory requirements.
Ensure that regulatory authorities’ requirements are met for products engineered, manufactured or sold by assigned division or product line.
Along with project engineer, ensures that each product complies with local, regional, and/or national registration, safety, and other required approvals before product is delivered to the customer.
Develop changes as required for labeling, manufacturing, marketing, engineering and clinical protocols for regulatory compliance.
Ensure that appropriate tracking and control systems exist.
EDUCATION AND EXPERIENCE:
Bachelor in a technical discipline or equivalent, 3 years working experience in regulatory affair management. Experience in the ultrasound product registration will be plus.
求职提醒:求职过程请勿缴纳费用,谨防诈骗!若信息不实请举报。