Regulatory Affairs Specialist III

2 weeks ago


Texas City, Texas, United States Aequor Technologies Full time

Job Description:

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

ssist with the coordination and scheduling of NB meetings for Alcon SMEs as required, including documenting and filing of NB meeting minutes.

Support NBL team and Alcon 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.
ctively 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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