Regulatory Affairs Consultant

Location: Colorado Springs CO
 Duration: 12 Months

 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 
 
 Key Deliverables – Key Success Factors: 
 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

Regards,
Vikas
Vikasy@apninc.com

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