Sr. Quality & RA Manager--某500强(中国)投资有限公司

Responsibilities:

Identify, foster and grow a harmonizedquality and regulatory organization across Ultrasound BIU. Liaise and leverageresource with other RA organizations within IS & PH.

Product Development portfolio: Providetimely QA & RA support to the planned US product development efforts toassure on time product release per R&D and Market agreed timelines.

Operations: Provide adequate QA support tothe operation team based in Shanghaito ensure timely shipment of high level of quality products to the customers.

Provide leadership and mentoring to theQuality assurance and quality control team.

Regulatory Compliance:  Support compliance, simplification andHarmonization of regulatory procedures.

Q&R team development: Establish andexecute plans to address development needs, growth, and succession planning.

Metrics: Develop and implement appropriatequality and regulatory metrics to facilitate tracking and monitoring of keyelement of the quality system, compliance, and regulatory activities.

Product Transfers: Liaise and supportproduct transfer project from otherUSfacilities to US.

Management Representative: Direct contactand representative for Apex when working with CFDA and other regulatoryagencies.

 

Qualification:

BS in engineering, life sciences, MS or MBApreferred

10 years Medical device Quality andRegulatory experience working inChinawith CFDA, FDA, and ISO.

3 to 5 years leadership/managerialexperience in Q&R field.

 Expertise in Quality and regulatory affairsstrategy & processes, forChinamanufacturers.

Regulatory Compliance requirementsknowledge for CFDA,US,EU,Japan,and emerging markets.

Managing CFDA, Notified Body, and otheragency meetings.

Surveillance of industry trends to assurecontinues compliance.