Smith & Nephew

Senior Regulatory Affairs Specialist (Columbia, MD)

Smith & Nephew(16 days ago)

HybridFull TimeSenior$101,500 - $152,250Regulatory Affairs
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About this role

Smith+Nephew is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for medical products including Human Cells, Tissues, and Cellular and Tissue-Based products, ensuring compliance with FDA regulations and supporting device-biologics combination products.

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Required Skills

  • FDA
  • Regulatory Strategy
  • 510(k)
  • HCT/Ps
  • Pre-Submissions
  • Compliance
  • Medical Devices
  • Biologics
  • Regulatory Affairs
  • FDA Interactions
Smith & Nephew

About Smith & Nephew

smith-nephew.com

Smith+Nephew is a global portfolio medical technology business. We design and make technology that takes the limits off living.

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