Quality Management System Expert

1 day ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Radiobotics ApS is a pioneering company that aims to solve the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and 1st line reported by our products, enabling non-specialists to safely and effectively handle imaging outside the hospital.

We are looking for a highly skilled QA/RA specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a central role in maintaining superior product quality and expanding our presence in new markets.

The successful candidate will have at least 1 year of experience within quality assurance and/or regulatory affairs, a master's degree in healthcare, medical, or life science, and excellent communication skills in English. They should also have knowledge of quality management systems and regulatory requirements within MDR and ISO 13485.

Your main tasks will include:

  • Co-driving product release projects in collaboration with the project manager from the development team
  • Supporting other departments in design control
  • Taking lead on risk analysis for new products, with support from our clinical and development team
  • Reviewing and revising QMS procedures to ensure they are efficient and effective
  • Assisting management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating product submissions for the devices we develop (possibly supported by consultants)
  • Training the company in QMS procedures
  • Participating in audits, both internal and external
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