Clinical Quality Assurance and Regulatory Affairs Specialist
2 weeks ago
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 JobAs 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 UsRadiobotics 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 OfferWe 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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