Associate Regulatory Affair Manager
§Develop and implementsRA 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 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).
- This position is a core team member to drive the global product for China registration
- Develop and execute product registration strategy in line with company business goals and maximize com-petitive advantages of company assets
- Develop and execute continuous improvement recommendations on standard/product 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 regulatory environment.
Recruiter:
Anna Wang (??), Sujan Raju G S