Jennifer Saylor

Post Market Surveillance Manager at OriGen Biomedical

Role
Post Market Surveillance Manager at OriGen Biomedical
Location
Austin, TX, US
LinkedIn followers
500 followers
Sales & Business DevelopmentView LinkedIn profile

About Jennifer Saylor

Biomedical Engineer with experience in medical device regulatory affairs including 510(k) preparation, EU & JPAL technical file preparation, design control and new product development. Also experienced in complaint handling and MDR reporting.Specialties: Lean Six Sigma, new product development, regulatory affairs, technical support

Experience

  1. Post Market Surveillance Manager

    OriGen Biomedical

    Jun 2024 — Present · Austin, TX, US

    Manage all complaint handling and post market surveillance activities, including vigilance reporting and product recalls.

Education

  • Villanova University

    Certificate, Lean/Six Sigma

    2010 — 2011

  • Virginia Commonwealth University

    B.S., Biomedical Engineering

    2000 — 2005

Skills

  • Biomedical Engineering
  • Design of Experiments
  • Manufacturing
  • Six Sigma
  • Quality Assurance
  • Iso 13485
  • Sop
  • Fda
  • Technical Support
  • Product Development
  • Design Control
  • Lean Manufacturing
  • Validation
  • Cross-Functional Team Leadership
  • Quality System
  • V&V
  • Regulatory Affairs
  • Lifesciences
  • Medical Devices
  • Capa

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Jennifer Saylor — Post Market Surveillance Manager at OriGen Biomedical in Austin, TX, US | Unifers