Compliance Specialist Medical Devices
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Antwerpen Belgium.
• 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
• 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
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.
The Company
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
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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