Compliance Specialist Medical Devices
SIRE
Antwerpen, Belgium
6 dagen geleden

The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Antwerpen Belgium. Our client is a professional Healthcare and Medical Devices and operates at an international level.

They are one of the leaders in technological developments and innovation. They are active within a broad range of technology-driven industries.

Role description

In this position you will be responsible for Field Change Orders. As a compliance specialist, you will be carefully analyzing documentation and you will identify issues in those files.

On a daily basis, you closely collaborate with the various sites to solve any issues. You are presenting the results to the Post Market Surveillance to check with authorities.

This project is set for a year and can be extended with additional year.

Responsibilities

  • Closely collaborating with various authorities
  • Providing feedback on Field Change Order execution documentation for the Quality & Regulatory improvement
  • Report and identify issues in the documentation
  • Key contact person regarding any issues with FCO
  • Requirements

  • Bachelor in Life Sciences
  • Minimal of 7 years of experience in a strongly regulated environment : Medical Device, Automotive, Aerospace, Pharma, or Biotech.
  • Team player, yet individual operator
  • Strongly skilled in coordinating across various departments
  • Excellent writing and verbal skills in English
  • Strong analytical skills and eye for detail
  • Excellent communication skills
  • Other information

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.

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