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Location: 

Kortrijk, BE

Date:  Oct 9, 2021
Job ID:  3250

Process Compliance Officer Healthcare

Barco designs technology that makes everyday life a little better. Seeing beyond the image, we develop sight, sound, and sharing solutions to help you work together, share insights, and wow audiences. Our focus is on three core markets: Enterprise (from meeting and control rooms to corporate spaces), Healthcare (from the radiology department to the operating room), and Entertainment (from movie theaters to live events and attractions). With a team of over 3,300 employees, located all around the globe, we realized sales of 770.01 million euro in 2020. 

As Process Compliance Officer Healthcare, you are responsible for creating an overall vision on all surgical medical devices residing in the Barco Software department. This focuses not only on the Nexxis OR video routing-over-IP solution for digital operating rooms but also on QAWeb, our online service for Quality Assurance of PACS displays. In this position you will be driving the successful creation and organisation of technical files for IEC62304 (international standard for medical device software), following up on medical device regulations and assisting with risk assessments. You work in the R&D team where you assist the teams in Belgium during the complete process life cycle of all Nexxis OR and QAWeb projects to guarantee all regulatory requirements are met and implemented. Needless to say that for this position it's key to have experience with medical device standards, with IEC62304 for SW development, FDA filings, security regulations for medical devices and you are familiar with UL certifications like 60601-1 (standard for electrical medical equipment).  

 

 

As our Software Process Compliance Officer Healtcare you will

 

  • Oversee and monitor the compliance program of the surgical software products you are responsible for
  • Own Risk Management together with the Product Owner
  • Lead and document risk management review meetings
  • Perform risk assessment on all incoming issues
  • Review and update system risk assessment and risk evaluation documentation
  • Risk Analysis Sessions with surgeons + processing of data in Risk Assessment Document
  • Oversee the Technical file (IEC62304)
  • Review of documentation linked to Technical File (per release) - process-wise + content-wise
  • Support the software team, Product Owner and Scrum Master for regulatory follow up per release
  • Follow-up technical file status in the project by organizing regulatory review meetings
  • Maintenance of technical File in the dedicated tool Ennov
  • Give Ennov trainings to the team where needed
  • Help to Integrate medical regulations in Agile workflow
  • Optimize benefits of medical regulation into Agile SW development workflow
  • Guide the R&D team with audit preparations + implementation if any audit findings

 

 

Your profile

 

  • You preferably hold a Master's Degree
  • Experience with medical standards is a must
  • You have high-level of expertise in risk management
  • You have experience with various medical disciplines, preferrably with a surgical focus
  • Having experience with UL auditing is required
  • Experience with SW development processes are a plus
  • Having experience with a hospital environment is an asset
  • You are fluent in Dutch and English, both spoken and written
  • You are a team player who focuses on quality, innovation and results
  • You have great organizing skills, and pay attention to details
  • You are willing to travel for short periods of time

 

 

What’s in it for you?

 

  • Be part of an international development team based in Belgium, Germany, US, India and Italy
  • Work in an agile (scrum) mode in the core of a global tech top employer
  • Appreciate the comfort of our brand new headquarters
  • Enjoy continuous training opportunities at our very own Barco University 
  • Take home a competitive salary package with attractive benefits