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Regulatory Affairs Specialist I

Fort Worth, TX 76134

Posted: 01/15/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 617026 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 40-44.88 **salary will be commensurate with experience 

Job Description:

* Compile and maintain regulatory documentation databases or systems. * Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU and Canada submissions). Communicate with internal stakeholders regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. * Coordinate, prepare, or review regulatory submissions for domestic or international projects. * Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. * Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Conduct regulatory impact assessment for post approval changes and support preparation of necessary submission documentation * Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. * Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. * Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. * Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. * Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. * Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. * Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. * Prepare or maintain technical files as necessary to obtain and sustain product approval. * Recommend changes to company procedures in response to changes in regulations or standards. * Review clinical protocols to ensure collection of data needed for regulatory submissions. * Write or update standard operating procedures, work instructions, or policies.
  

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 is an equal opportunity employer. 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.