This position is a core team member to drive the China registration for the global products.

Develop and execute product registration strategy in line with company business goals and maximize competitive advantages of company assets.

Develop and execute continuous improvement recommendations on regulaton/ standard/ technical guidance and provide insights to stakeholder and dedicated RA team.

Build and maintain good and professional relationship with regulatory authorities to ensure smooth and efficient registration process and make possible positive change of reguIatory environment.

Education / 教育背景

A Master/Bachelor’s Degree, medical/science background is preferred.

Experience /经验

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

5+ years regulatory working experience in medical device company.

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 spirit.

Proven record of successful completion of complex tasks.

Familiar with NMPA regulation/standard/technical guidance, and international reglation/ standard, FDA, MDR, JPAL, KFDA regulation knowledge is preferred.

Knowledge of ISO13485/ ISO14971/ ISO14155 is preferred.

Familiar with ophthalmic devices is preferred.

Willing to travel if necessary.

Develop and implement RA strategy for global product 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 growth.

Advocate 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 compliance.

Communicate standard/technical guidance changes to global RA/CA in a timely manner, and provide insights to comply 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 perspective.

Leverage internal and external resources for RA strategy & plan to meet registration requirements and advise regulatory requirements during product design stage proactively.

Additional tasks as assigned by RA function head.

This position is required to assure compliance of company operations to all applicable laws, reg­ ulations and standards, good business practices and company documented procedures (includ­ ing knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).