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Regulatory Affairs Specialist III

Fort Worth, TX 76102

Posted: 05/28/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 607610 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 59.27-76.65**salary will be commensurate with experience 

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 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Fort Worth, TX

Ready to embark on an exciting career journey in Fort Worth, Texas? Explore our job listings in this vibrant city known as the 'City of Cowboys and Culture.' Fort Worth offers a perfect blend of rich Western heritage and modern amenities, making it an ideal destination for job seekers looking for growth opportunities and a high quality of life. From the iconic Fort Worth Stockyards to the world-renowned Kimbell Art Museum, there is something to enchant everyone here. Indulge in mouthwatering Tex-Mex cuisine, catch a show at the Bass Performance Hall, support the revered Fort Worth Symphony Orchestra, or cheer on the Dallas Cowboys at AT&T Stadium. Come discover why Fort Worth is the perfect place to take the next step in your career and experience its irresistible charm firsthand.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.