Clinical Quality Assurance and Regulatory Affairs Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

We are seeking an experienced Clinical Quality Assurance and Regulatory Affairs Specialist to join our team at Radiobotics ApS. The ideal candidate will have a strong background in quality assurance and regulatory affairs within the medical device industry.

About the Job

As a Clinical Quality Assurance and Regulatory Affairs Specialist, you will play a key role in maintaining superior product quality and ensuring compliance with regulatory requirements. 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 the risk analysis for new products, with support from our clinical and development team
  • Reviewing and revising QMS procedures to ensure that they are efficient and effective
  • Assisting management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating the product submissions for the devices we develop (possibly supported by consultants)
  • Training of the company in QMS procedures
  • Participating in audits, both internal and external

The ideal candidate will have a master's degree in healthcare, medical or life science, and at least 1 year of experience within quality assurance and/or regulatory affairs. You should be able to structure your tasks efficiently and deliver on time.

About Us

Radiobotics ApS is a leading provider of radiology solutions, driven by a mission 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.

What We Offer

We offer a competitive salary of DKK 120,000 - 180,000 per year, depending on experience, as well as flexible working hours, free coffee/tea, social gatherings, free office snacks, free Friday beers, and near public transit.



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