Senior QA/RA Expert for Radiobotics ApS

3 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

About Senior QA/RA Expert for Radiobotics ApS

We are a dynamic and innovative company dedicated to solving 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 first-line reported by our products.

We are seeking a Senior QA/RA Expert to join our Clinical and Regulatory team. As a key member of our team, you will be responsible for defining and delivering our strategy to maintain superior product quality and regulatory compliance.

The successful candidate will have a strong background in quality assurance and/or regulatory affairs, with experience in quality management systems and regulatory requirements within MDR and ISO 13485. You will be expected to review and revise QMS procedures, assist management in prioritizing regulatory approval activities, and participate in audits.

Your main responsibilities will include:

  • Leading 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 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 the company in QMS procedures
  • Participating in audits, both internal and external

To succeed in this role, you will need excellent communication skills in English and experience with working within or leading cross-functional projects. Knowledge of software as a medical device and a positive can-do attitude with a thorough and structured mindset are also essential.

We offer a competitive salary and a range of benefits, including flexible working hours, free coffee/tea, social gatherings, free office snacks, and free Friday beers.

At Radiobotics ApS, we believe in transparency, integrity, and pursuing big ideas. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other.



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