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Regulatory Affairs Expert for Medical Devices

2 weeks ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

We are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We believe in integrity, transparency, and open communication. Our vision is to augment routine X-rays of the musculoskeletal system, enabling non-specialists to read radiology images assisted by our products, and ensuring patients have access to immediate expert-level evaluation of their imaging.

We are looking for a highly skilled Regulatory Affairs Expert for Medical Devices to join our team. In this role, you will play a critical part in developing and implementing regulatory strategies, collaborating with cross-functional teams to ensure compliance with regulatory requirements, and contributing to the company's mission to revolutionize the field of radiology.

The ideal candidate will have extensive experience in regulatory affairs within the medical device industry, a strong understanding of quality management systems and regulatory requirements, and excellent communication skills. You will be responsible for reviewing and revising QMS procedures, assisting management in prioritizing regulatory approval activities, and creating and coordinating product submissions.

We offer a competitive salary and benefits package, flexible working hours, and a dynamic work environment that encourages collaboration and innovation. If you are passionate about regulatory affairs in the medical device industry, we encourage you to apply for this exciting opportunity.