Location: Fort Worth, TX
Position Type: Contract

Job Description:
* Support the NBL Manager in Lifecycle Change Management projects.
* Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of regulatory support, review and approval of applications with the demonstrated ability to act independently to execute to foster and drive right first-time submissions.
* Driving on-time processing, submission, and oversight of Change Notification submissions to support facility business needs, to project completion.
* Maintaining in-house tracking tools to track NB submissions for all Notified Body projects.
* Support the maintenance of Product and QS EC Certificates (MDD /MDR) and associated documentation.
* Assist with the coordination and scheduling of NB meetings for client SMEs as required, including documenting and filing of NB meeting minutes.
* Support NBL team and client QMS in coordination and execution of NB audits.
* Collaborate with the MDR PMs, GRA strategists and cross- functional teams to support MDR Sub. Strategy and implementation timelines.
* Support the NB Budget process and processing of NB financial invoicing.
* Actively contribute to the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification reporting requirements
* Support the implementation of project related "regulatory excellence " activities as part of QS continuous improvement initiatives.

Must Haves:
* Must have Medical Device experience. (Not Pharma)
* European MDR Experience
* Manufacturing background
* 4 Years of experience minimum (pure medical devise)