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Rebeka Stoltman

Director, Regulatory Affairs

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

Experience

  1. Director, Regulatory Affairs

    Boston Scientific

    Aug 2019 — Present

Education

  • Cardinal Stritch University

    MBA

  • University of Wisconsin-River Falls

    Bachelor of Science, Chemistry/Biochemistry

Skills

  • Verification and Validation (V&V)
  • Regulatory Requirements
  • Regulatory Affairs
  • Clinical Trials
  • Manufacturing
  • Quality Management
  • Quality System
  • V&V
  • U.s. Food and Drug Administration (Fda)
  • Medical Device Directive
  • Product Development
  • Validation
  • Product Launch
  • Quality Control
  • Gmp
  • Iso 13485
  • Medical Devices
  • Capa
  • Design Control
  • Cross-Functional Team Leadership
  • Iso 14971
  • Corrective and Preventive Action (Capa)
  • Regulatory Submissions
  • Ce Marking
  • Iso
  • Fda
  • Biomedical Engineering
  • Quality Assurance
  • Pma
  • Change Control

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Rebeka Stoltman — Director, Regulatory Affairs at Boston Scientific in Minneapolis, MN, US | Unifers