Regulatory Affairs Consultant for Medical Devices

2 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

We are Radiobotics ApS, a company driven by aspiration, curiosity, and playfulness. Our mission is to solve the global need for radiologists while ensuring every patient receives expert-level care. We strive to learn what happens beyond the surface and engage with each other in a fun and dynamic environment.

We are seeking a highly experienced QA/RA specialist who can work independently and as part of a cross-functional team. The ideal 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.

The successful candidate will be responsible for defining and delivering on our strategy to maintain superior product quality, taking lead on placing our products into new markets, and ensuring our internal quality processes are well-oiled. They will also assist in creating and coordinating product submissions, reviewing and revising QMS procedures, and participating in audits.

As a member of our team, you will enjoy flexible working hours, free coffee and tea, social gatherings, free office snacks, and free Friday beers. Our office is conveniently located near public transit, making it easy to commute.



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