Develop and implements RA strategy for global products registration in China, esp to communicate with Chinese authority & global team on product compliance to ensure submission and approval in line with biz plan to enable biz growthAdvocate insights for specific emerging standard/technical guidance/regulatory requirement to RA team and stakeholder,  collaborate with team to build and execute relevant RA process/WI to ensure complianceCommunicate standard/technical guidance changes to global RA/CA in a timely manner,  and provide insights in meetings and complying with new requirements for projects under assigned team Enhance and maintain good relationship with Chinese authorizes to facilitate review and approval effectively, take initiatives to work closely with standard committees/relevant parties to advise comments as key opinion leader in draft stage on behalf of Zeiss from technical perspectiveLeverage internal and external resources for RA strategy & plan in meeting registration requirements and advice regulatory requirements during product design stage proactively.Additional tasks as assigned by RA function headThis position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).   

Education / 教育背景

A Master/Bachelor’s Degree in medical/science

Experience /经验

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

5 years regulatory working experience in medical device company.

Other skills /其他技能

Good communication, facilitation and problem-solving skillsCommunicate 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 preferredKnowledge of ISO13485/ ISO14971/ISO14155 will be preferredFamiliar with ophthalmic devices is preferredWilling to travel if necessary.

Your ZEISS Recruiting Team:

Qiong Wang （王琼）, Xiaojun Yang （杨晓君）