Post Market Surveillance SME

Jacksonville, FL

Job ID: 131860 Industry: Medical Device

 

Post Market Surveillance SME

As a Post Market Surveillance SME, you will use your expertise and knowledge of medical device Quality Management Systems to manage the QMS updates required by European Union (EU) Medical Device Regulation (MDR). In this role you will be responsible for managing the transition/deployment of the QMS updates and manage its deployment in preparation for EU MDR compliance. This role will be responsible for administering a compliant and effective QMS that is in alignment with EU MDR, along with locally managing plans for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS. You will administer and contribute to the management of local QMS documents, and supports training and training administration as per the QMS and contributes to training content for local QMS documents as necessary. In addition to local BIU QMS update management you will support other DI quality initiatives in support of the EU MDR program. Some of these additional responsibilities include, but are not limited to, Post-Market Surveillance support and technical documentation quality reviews. You will partner with other key quality and post market surveillance professionals to drive consistently good customer feedback tools and methodology and are consistently practiced within the client, contributing to proper understanding of device performance in clinical settings. 


Your responsibilities: 
o Support Post Market QMS activities for EU MDR compliance 
o Manages the transition/deployment of the PQMS and manage its deployment. 
o Administers a compliant and effective QMS for the activities in scope 
o Locally manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS 
o Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing, and Complaint Management teams and international geographies to develop a QMS deployment strategy for multiple BIUs 
o Work closely with other regulatory and clinical professionals to ensure all post market product data and clinical use information is adequately and correctly represented 
o Analyzes complaint data, gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the market 
o Participate in cross-functional meetings to provide detailed feedback of QMS, post market, and other quality implementation activities Knowledge of how to, or a willingness to learn to write protocols, reports, and other documentation to support international registrations 
 

Required:
Post Market Surveillance
Complaints
QMS
Medical Device

Plus:
EU MDR

Job Type: Contract

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