Regulatory Affairs Specialist III

4 weeks ago

Fort Worth, United States Mitchell Martin Full time

Our client, is a Swiss-American pharmaceutical and medical device company, is seeking a Regulatory Affairs Specialist III

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)

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