Regulatory Affairs Specialist III
500 Taylor St, Fort Worth, Tx 76102 Fort Worth, TX 76102 US
Job Description
Job Description:Â
•           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 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 SMEs as required, including documenting and filing of NB meeting minutes.
•           Support NBL team and 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.
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