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Regulatory Affairs Specialist

3 months ago

Fort Worth, Texas, United States TalentBurst, an Inc 5000 company Full time

Position: Regulatory Affairs Specialist III, Req#: 2797-1

Location: Fort Worth, TX (100% Onsite)

Duration: 6+ Months Contract

Job Description:

Must Haves:

  • Must have Medical Device experience. (Not Pharma)
  • European MDR Experience
  • Manufacturing background
  • 4 Years of experience minimum (pure medical devices)

Job Description:

  • Support the NBL Manager in Lifecycle Change Management projects.
  • Proactively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of regulatory support, reviewing 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 the client 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 the client's SMEs as required, including documenting and filing NB meeting minutes.
  • Support the NBL team and the client's QMS in the 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.