Regulatory Affairs Specialist for Medical Devices

11 hours ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time
About Radiobotics

Radiobotics is a dynamic company on a mission to revolutionize the field of radiology. Our vision is to make expert-level care accessible to every patient, and we're committed to achieving this goal through innovative solutions.

Job Summary

We're seeking an experienced QA/RA specialist to join our Clinical and Regulatory team. As a key member of our team, you'll play a crucial role in maintaining superior product quality and driving business growth through strategic market placement.

About the Role

The ideal candidate will have at least 1 year of experience in quality assurance and/or regulatory affairs, with a strong understanding of medical device regulations, including MDR and ISO 13485. You'll be responsible for co-driving product release projects, supporting design control, and reviewing QMS procedures to ensure efficiency and effectiveness.

You'll also assist management in prioritizing regulatory approval activities, create and coordinate product submissions, train the company in QMS procedures, and participate in audits.

Key Responsibilities:

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