Senior Regulatory Affairs officer

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Goals/Mission:
- Ensure medical products and process complying with relevant international and national standards and regulations. He or she reports to Regulatory Affairs manager.

Working Partners/Contacts:
Internal: In charge of group of regulatory affairs, supporting PL and SC on compliance of relevant standards and regulations for new products.
External: legal authorities, testing institutes, and contacts on regulatory issues in Siemens healthcare.

Tasks:
- Ensure product and process compliance with relevant and international laws and regulations.
- Establish and maintain product market clearance and other compulsory certification process
- Responsible for market clearance and other compulsory certificate for new product
- Communicate with Government office and Siemens internal relevant organization to set up a network to improve market clearance process
- Cooperate and Coordinate closely with new project team to ensure market clearnce and other compulsory certificate process smoothly and efficiently
- Well communicate with business unite about the progress and status
- Responsible for coordination of factory inspection from third party
- Regulatory knowledge consultant for team member



Education:
- Bachelor or above

Knowledge/Languages:
- Related standard/regulation/laws for medical device
- Language (English)


Experience:
- At least 5 years experience in Regulatory affairs
- Experience with indenpendently completion of market clerance for a certain product in China or other countries.
- Good communication skill with foreigner