If you have some relevant experience in QA and/or RA for Medical Devices, then this might be a great opportunity for you:  We are looking for a RA/QA Manager Medical Devices Software.

Mission:

• Manage all activities as required by the (integrated) Quality Management System which is built according to the requirements of both ISO 13485:2016 and ISO 27001:2013 and ensure they are carried out in a manner that is compliant with the applicable regulatory requirements.
• Define the strategic roadmap for NDTE, such as compliance to additional standards or define constraints and boundaries for its product suite.
• Perform work for required activities as defined in the QMS or the roadmap.

Job Responsibilities:

• Manage quality in the product development lifecycle
  • Setup / improve review processes, design verification and validation processes and change control processes
• Conduct (patient and security) risk management activities
  • Risk analysis
  • Setup and follow-up on risk reduction activities
  • Document and keep procedures up to date
• Manage quality events
  • Handle non-conformances
  • Setup / improve customer complaint processes
  • CAPA activities
  • Document and keep procedures up to date
• Documentation management
  • Ensure policies, procedures and instructions are compliant and kept up to date
  • Ensure the medical device file(s) are compliant and kept up to date
• Training management

Profile & Skills:

• Master’s Degree in Life Sciences or Engineering or similar by experience
• Knowledge of MDR/IVDR
• Relevant experience in Quality Assurance and/or Regulatory Affairs for medical devices
• Knowledge on medical device quality management for software as a medical device
• Fluent in English
• Comfortable working in a full digital environment
• Experience with software development activities is a plus
• Excellent communication skills
• Reside in Belgium