Karin Desjardins

Role
Director, Regulatory Affairs at Boston Scientific
Location
Boston, MA, US
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

Experience

  1. Director, Regulatory Affairs

    Boston Scientific

    Sep 2022 — Present

Education

  • Northeastern University

    MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices

    2005 — 2008

  • Northeastern University

    BS, Business Administration

    2000 — 2004

Skills

  • Establishment Registration / Device Listing
  • Batch Search Strategy
  • Business Process Improvement
  • Cross-Functional Team Leadership
  • Gmp
  • 510(K)
  • Regulatory Affairs
  • Regulations
  • Design Control
  • Source List Indicator
  • Iso 13485
  • Regulatory Compliance
  • Regulatory Requirements
  • Policy Writing
  • Leadership
  • Product Development
  • Medical Devices
  • Regulatory Submissions
  • Validation
  • Quality System
  • Fda
  • Import/Export
  • Strategy
  • Foreign Trade (Legal Status)
  • U.s. Food and Drug Administration (Fda)
  • Regulatory Distribution Controls
  • Capa

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Karin Desjardins — Director, Regulatory Affairs at Boston Scientific in Boston, MA, US | Unifers