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Regulatory Compliance Engineer

Req ID: J2262542

  • Ubicación
    Monumento, CO, Colorado, United States of America
  • Categoría Riesgos y Garantias
  • Publicado martes, 23 de febrero de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

To enhance our Team of Global Compliance, we are looking for:

Regulatory Compliance Engineer

Your Responsibilities include and are not limited to:

  • supporting internal audits and supplier audits,
  • supporting the readiness program for ISO Registration audits, FDA Inspections and customer audits
  • Acting as supporting compliance contact for site departments, business units, and corporate functions
  • Understand, implement and maintain Compliance programs.
  • Support the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, Anvisa)
  • Supporting the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
  • Performing all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements

What will you bring:

  • Educational background in one (or more) of the following fields: Quality, Regulatory, Engineering, Business or Life Sciences
  • 3 + years of industry experience within Quality and/or Regulatory
  • Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
  • Good computer skills; Word, Excel, PowerPoint
  • Good interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally
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