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Regulatory Operations Spec

Memphis, TN 38132

Posted: 12/05/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 591564 Is job remote?: Yes Country: United States

Job Description


HM's Top Needs:
  1. Bachelor's degree in a relevant field, such as life sciences, engineering, or business administration.
  2. Working knowledge of UDI standards and regulations, such as FDA 21 CFR Part 830, ISO 15223-1, and EU MDR.
  3. Ability to work independently and collaboratively in a fast-paced environment.

Education Required: Bachelor's degree in a relevant field, such as life sciences, engineering, or business administration.

Years’ Experience Required: 0-3 years

Will the contractor be working 40 hours a week? Yes If not, weekly estimate?

Do they need to be local to any MDT office and if so where? Prefer candidate local to Memphis in a Hybrid setting. Will accommodate remote for right candidate.

Job Summary 
 
The UDI Data Collection and Regulatory Operations Specialist is responsible for collecting, validating, and submitting UDI data to various regulatory authorities, as well as maintaining and updating the UDI database and related documentation. The UDI Data Collection and Regulatory Operations Specialist will also support other regulatory operations activities, such as product registration, submission management, compliance monitoring, and regulatory project management. 

 

Job Responsibilities 
  • Collect, validate, and submit UDI data to FDA, EUDAMED, and other regulatory authorities, in accordance with the applicable standards and regulations. 
  • Maintain and update the UDI database and related documentation, ensuring data accuracy and completeness. 
  • Coordinate with internal and external stakeholders, such as product development, quality, marketing, labeling, and suppliers, to obtain and verify UDI data and resolve any issues or discrepancies. 
  • Support other regulatory operations activities, such as product registration, submission management, compliance monitoring, and regulatory project management, as needed. 
  • Perform other duties as assigned. 

 

Job Qualifications 
  • Bachelor's degree in a relevant field, such as life sciences, engineering, or business administration. 
  • Experience in UDI data collection and submission preferred, but not required
  • Working knowledge of UDI standards and regulations, such as FDA 21 CFR Part 830, ISO 15223-1, and EU MDR. 
  • Experience with UDI database systems, such as GUDID, EUDAMED, and GS1 preferred. 
  • Excellent communication, organizational, and problem-solving skills. 
  • Attention to detail and accuracy. 
  • Ability to work independently and collaboratively in a fast-paced environment. 
  • Proficient in Microsoft Office applications, such as Word, Excel, and PowerPoint. 

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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Although this hasn't been an issue at The Planet Group, 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 The Planet Group.

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