RA supervisor
Carl Zeiss AG
Date de publication :
15 août 2024Taux d'activité :
100%- Lieu de travail :Beijing
- Fully proficient in collaborating with RA team to develop and execute RA strategy for product registration from technical perspective in an effective manner whenever necessary
- Develop 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.
Contact
Carl Zeiss AG