CASY-MSCCN Jobs

Purpose:

• The Post Market Surveillance (PMS) manager is responsible for the planning and management of post-market surveillance activities for Personal Health products in China. The role ensures compliance to both local and global regulatory requirements affecting PMS and provides a closed-loop system from post market data collection, interpretation to continuous quality improvement, and ultimately drive for consumer satisfaction. Additionally, the Post market surveillance manager manages and continually improves the PMS processes.

Your Responsibility:

• Manage post-market surveillance process and activities for Personal Health products in China.

• Manage local- and support global- product scope on monitoring and reporting on metrics of PMS activities. Facilitate periodic quality reviews in accordance with local and/or global requirements, as well as business needs.

• Provide inputs to pre-market risk analysis based on the information obtained from post-market data.

• Drive actions from product surveillance to improvements with cross-functional team in China.

• Organize the collection of all information needed for the creation of PMS plans, reports and periodic quality reviews.

• Generate PMS plan and report according to local and/or global requirements, as well as business needs.

• Support in complaint handling and identifying new potential risks as a result of complaint investigations and/or trends.

• Represent PMS in both internal and external audits in China.

• Supporting C&R process for China L4L products

• Participate as the PMS representative in the review and approval of Issue Impact Assessments and Health Hazard Evaluations

You're the right fit if:

• Bachelor’s Degree, preferably in engineering, science, healthcare, or quality related profession.

• 6+ years’ experience in Quality/PMS in Consumer (Electro) goods, Medical Devices and/or other regulated industries.

• Experience in managing activities with China authorities, such as NMPA(CFDA), Administration for Market Regulation, and handling with National consumer product recall integrated management information system-nice to have.

• Be a driver of efficiency improvement, and able to work in a fast-moving environment required.

• Be capable of driving cross-function teamwork with a high degree of initiative, engagement, self-motivation, and flexibility.

• Strong written and oral communication skills in English and Chinese required and demonstrated ability to effectively communicate technical content to a variety of audiences.

• Good analytical skills and process improvement capabilities.