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MILabs is a leading global player in biomedical imaging, located in Houten and Utrecht, the Netherlands. With its state-of-the-art imaging devices MILabs is a highly valued provider of PET, SPECT, Optical and X-Ray CT imaging technologies for world leading universities, academic hospitals, CRO’s and pharmaceutical companies that use MILabs equipment to develop new diagnostic tools and treatments against e.g. infections, cancer, cardiac problems and neurodegenerative diseases. Our team of employees and collaborators includes leading innovators in biological and medical imaging. Our culture celebrates diversity and entrepreneurialism and prizes the unique contribution of each employee.
To facilitate further growth, MILabs is looking for a dedicated

QA/RA Manager

The Quality Assurance / Regulatory Affairs Manager is responsible for executing and coordinating all the activities related to the Quality Management System (QMS) and to the regulatory processes.

Your responsibilities

  • Describing, implementing and continuously improve the Quality Management System
  • Provide guidance, instruction and determine quality related training for targeted personnel
  • Lead internal and external audits and report the results to management
  • Maintain a good documentation and record management system
  • Responsible for appropriate licensing and product registration of (pre) clinical product portfolio
  • Ensuring that relevant regulatory requirements are met, communicated, and operated by the responsible staff in the organization
  • Maintaining contact with authorities of QMS and product certification
  • Implementing and maintaining Complaint Handling and Vigilance System or reporting to customers according to applicable regulatory requirements
  • Initiation of and implementation of an effective Corrective Action and Preventive Action process

Your profile

  • BSc/MSc degree in scientific discipline or related field
  • Minimum of 10 years’ work experience in a similar environment
  • In-depth knowledge of:
      • Implementing and maintaining all requirements of a Quality Management System meeting the standards ISO 9001 and ISO 13485
      • Regulatory standards (e.g., IEC 60601 series, IEC 62304, IEC 62366, ISO 14971)
      • Technical documentation under the EU-MDR 2017-745 and US FDA-QSR, 510(k)
  • Analytical, communication and interpersonal skills
  • A positive attitude and will take the lead for the responsible projects
  • Computer skills, including database management, Word processing, and spreadsheets
  • The ability to speak and write English fluently

MILabs offer

  • A competitive salary, depending on your education, skills, and experiences
  • A pension scheme (50 percent is paid by MILabs)
  • 25 holidays based on full-time employment plus national holidays
  • 8 Percent holiday allowance
  • Commuting allowance

We offer a unique and highly dynamic environment: you have the chance to contribute to the expansion of our cutting-edge technology throughout the worldwide research community. The working climate at MILabs is informal and internationally oriented.

If you are interested and looking for a new challenge in an innovative international organization, please mail your resume and motivation letter via ‘Apply’ button

**If you are an intermediary, please do not contact us**

 

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