Senior QA/RA Expert for Medical Devices

7 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

About Us

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Radiobotics is a dynamic company that values innovation, integrity, and transparency. We strive to solve the global need for radiologists while ensuring every patient receives expert-level care.

Our Mission

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We aim to augment routine X-rays of the musculoskeletal system and enable non-specialists to report them assisted by our products. This will ensure patients have access to immediate expert-level evaluation of their imaging and facilitate safe handling of non-critical imaging outside the hospital.

Your Role

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As a QA/RA specialist, you will become an expert in all corners of our Quality Management System and help define the structure of technical documentation. You will support other departments in design control and participate in audits, both internal and external.

Main Responsibilities

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

Requirements

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The ideal candidate will have at least 1 year of experience within quality assurance and/or regulatory affairs and be familiar with working with quality and regulatory processes within the medical device field. They should also possess a master's degree in healthcare, medical or life science, and have excellent communication skills in English.

Benefits

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We offer a competitive salary, flexible working hours, free coffee/tea, social gatherings, free office snacks, free Friday beers, and near public transit.



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