北京招聘

Sr Quality PMS Specialist

Responsibilities may include the following and other duties may be assigned.

The incumbent is responsible for post market surveillance (PMS) activities including customer experience (quality complaint), Field Corrective Action (FCA), Adverse Event (AE) monitoring, Advertisement (AD) review and support the team leaders to respond regulatory inquiry and post market sampling as per allocated Operation Unit (OU) pipeline.

• Provides administrative expertise in receipt, processing, monitoring and reporting of product defect complaints, serving as primary contact.
• Addresses and expedites product complaints under the company's complaint policy and procedures and ensures compliance with government regulations.
• Monitors complaint activity, maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure.
• Provides technical expertise to optimize complaint processing systems.
• Monitors the company's medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Periodical Risk Analysis Reports (PRARs), Risk management reports (RMRs), Adverse Event (AE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of AE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of AE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

• Collaborate with global FCA functions to implement medical device recalls, ensures the FCA are properly planned, approved by relevant functional leaders and appropriately reported to the local regulatory authority as per the specified regulations.
• Closely cooperate with OUs to maintain the appropriate and necessary communications to ensure the FCA are fully aware and understood so that to facilitate the execution.
• Maintain close and in time follow up with the regulatory authority to ensure all the FCAs (local and oversea) are appropriately reported, reviewed and approved by regulatory authority.
• Review the brand promotion materials, in any format and media, with the purpose to comply with the relevant advertisement regulations.
• Provide clear guidance and directions to the OUs concerning the appropriate promotion of the pipeline products.
• Submit the AD promotion materials and support to obtain the AD approval No. so that to meet OU needs
• Pay close attention to regulation trend and explore much friendly suggestions concerning the promotion materials advisory.
• Master product knowledge, familiar with product complaints and the reported AEs, so that able to collect information and support the PMS leader to response to the regulatory authority inquiries and post market quality inspection activities.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.