§ Develop and implement RA strategy for China registraion, 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 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 perspective
§ Leverage 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 head
This 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).