Fully proficient in collaborating with RA team to develop and execute RA strategy for product registration from technical perspective in an effective manner whenever necessaryDevelop and execute continuous improvement recommendations on standard/product technical guidance and provide insights to stakeholder and dedicated RA team

Experience /经验

5+ years working experience in the medical field, and the following experience will be preferred:

Have basic knowledge of electrical/electronic engineering, experience of product development process will be preferred.Familiar with medical EMC testing, standards, equipment, and facilities, have good EMC system understanding and background knowledge, and be able to perform trouble shooting during NMPA registration testing.Familiar with safety regulation and standards will be better, including but not limited to GB 9706.1:2020/ IEC 60601-1 ed.3 series, usability assessment, risk analysis, reliability, and environmental test.Working experience of testing institutions or projects experience cooperated with NMPA labs.Good technical document writing capability for NMPA registration supporting.

Other skills /其他技能

Good communication, facilitation, and problem-solving skills.Communicate effectively in English both verbally and in written form. Good computer skills, profeciency in office software. Strong strategic problem-solving and project management skills.Strong cross-function collaboration capability and good teamwork sprit.  Proven record of successful completion of complex tasks.Familiar with CFDA regulations/standards/technical guidance, and international regulations/standards， FDA, MDD, JPAL, KFDA regulation knowledge will be preferred.Knowledge of ISO13485/ ISO14971/ISO14155 will be preferred.Familiar with ophthalmic devices is preferred.Willing to travel if necessary.