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Document Processor III

San Diego, CARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300352
 

Document Processor III

 

Job Summary

The client is looking for a regulatory affairs consultant to work with R&D teams on various programs (e.g. IDE, manufacturing). This individual will assist R&D teams in developing regulatory strategy, regulatory plans and protocols, and creating submission documentation. 

Job Responsibilities

  • Regulatory strategy guidance for client teams 
  • Development of regulatory plan and protocols 
  • Development of regulatory submission documents 
  • Facilitate implementation of new Regulations such as EU Medical Device Regulations 
  • Participate in NPD as the Regulatory core team member 
  • Review of documents and project deliverables including but not limited to: 
    • Clinical Evaluation Reports (CER) 
    • Risk Management files 
    • Verification and Validation Reports 
    • Labeling

Education & Qualifications 

  • Experience working in international regulatory affairs 
  • Ability to provide strategic and execution-level regulatory affairs support (e.g. draft regulatory filing documents) 
  • Experience reviewing regulatory affairs elements of Clinical Evaluation Reports (CER), Risk Management files, Verification and Validation Reports, labeling 
  • Experience with disposable devices (e.g. guidewires/catheters/sheath introducers) would be preferred as an understanding of materials, biocompatibility, and sterility would be beneficial 

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/300352