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Regulatory Affairs Specialist

  • Specialty:

    Engineering
    • City:

      West Sacramento
    • State:

      CA
    • 95691
  • Assignment Type:

    Contract
  • Job Id:

    56352
  • Payrate:

    $40.53

Description

As a member of the Microbiology Quality & Regulatory Affairs department, your assignment will support key functional responsibilities, and compliance projects. Performs regulatory affairs functional responsibilities in support of new product development and commercialization. Support Regulatory Affairs for IVDR project tasks such as review and approval of clinical summaries; creation, assembly, and review of STED documents. 

Requirements of the Regulatory Affairs Specialist:

  • Bachelor’s degree in field with +2 years exp. OR Master’s degree in field with 0-2 years of experience working with regulatory requirements and agencies; specifically, FDA, IVDD and ISO 13485 required.
  • In-depth knowledge of MicroScan product development and RA experience
  • Experience with the IVDD/IVDR product requirements and 510(k) clearance process 
  • Microbiological Auto ID/AST products, hardware & software
 
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 

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Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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