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Senior Compliance Specialist

Req ID: J2251611

  • Location
    Mezzovico, Switzerland
  • Category Risk & Assurance
  • Posted Thursday, October 15, 2020
  • Type Regular Full time

Job Description

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

Senior Compliance Specialist

to lead assigned Quality System processes.

Your Responsibilities include and are not limited to:

  • Leading internal audits and supplier audits,
  • Leading the readiness program for ISO Registration audits, FDA Inspections and customer audits
  • Preparing submissions and responses to FDA and ISO Registrars
  • Acting as the primary compliance contact for site departments, business units, and corporate functions
  • Acting as a subject matter expert for the Quality Systems and Compliance programs.
  • Ensuring 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
  • 6 + 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)
  • Experience with compliance assessments, gap assessments and risk assessments.
  • Experience with program change management practices, lean or six sigma, program and system integration effort.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

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