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Post Market Surveillance Coordinator

Date: Feb 10, 2021

Location: Mortsel, BE

Company: Agfa-Gevaert NV

 

As Post Market Surveillance Coordinator, you will be part of our Post Market Surveillance team in Belgium. It concerns a highly accountable role in which you contribute to the PMS processes and activities in our Radiology Solutions division. You will make a difference, and are an added value to our business processes.


Your Responsibilities


•    Write and maintain complete Post Market Surveillance Reports for existing Medical Devices in compliance with regulations;
•    Organize Post Market Surveillance data gathering, interpret and analysis together with Agfa’s business partners in service, marketing and clinical experts;
•    Interpret and assess standards, guidance’s and regulatory assessments;
•    Maintain methodologies and procedures for the PMS team, based on the European regulations (MDR, MEDDEV 2.7.1 rev4), the FDA regulations (FDA 21 CFR 820), and the applicable quality standards (ISO 9001 and ISO 13485)
•    Working together with a team of QARA specialists and the Clinical Medical Officer CMO office to keep our Post Market Surveillance up to date,

•    Provide prediction models on complaints and incidents to be pro-active on service management and risk management for our product portfolio.


Requirements


•    You have an University degree; Medical Sciences, Engineering, Computer Science, Statistics or equivalent;
•    You are fluent in English, other languages such as Dutch are an asset.
•    Extensive and demonstrable knowledge of statistical methods and relevant statistical software such as R;
•    Computer proficiency in MS Office applications;
•    Experience in handling of big data sets.

 

Skills (preferred)


•    Knowledge of the specific standards and requirements for Vigilance Reporting and Post Market Surveillance;
•    Knowledge of clinical application of Radiology Systems;
•    Knowledge of project management;
•    Excellent written and verbal communication skills;
•    Strong organizational skills and pay attention to detail;
•    Experience in working in a very structured and process environment, mainly focused on medical devices regulations;
•    Striving for excellence in everything you do.

 

What we offer now and in the future

 

  • A dynamic global organisation with a history of innovation and strong product portfolio.
  • A challenging environment combined with a supportive management structure.
  • Career development and growth.
  • A competitive salary and benefit package.
  • A friendly work environment surrounded by dedicated and professional colleagues.

 

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About our company

Agfa-Gevaert Group; The Agfa-Gevaert Group develops, manufactures and distributes an extensive range of analogue and digital imaging systems and IT solutions, mainly for the printing industry and the healthcare sector, as well as for specific industrial applications.


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