Medical Device Quality Assurance Specialist

20 hours ago


Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time
About the Role:

This is an exciting opportunity to join our team as a Medical Device Quality Assurance Specialist. As a key member of our Clinical and Regulatory team, you will be responsible for ensuring that our medical devices meet the highest quality standards. Your expertise in quality assurance and regulatory affairs will play a crucial role in driving our business forward.

Key Responsibilities:
  • Co-driving product release projects in collaboration with the project manager from the development team
  • Supporting other departments in design control
  • Taking lead on 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

About Us:
Radiobotics is a dynamic and innovative company that is committed to providing high-quality medical devices. Our mission is to solve the global need for radiologists while ensuring every patient receives expert-level care. We are driven by aspiration, curiosity, and playfulness, and we strive to learn what happens beyond the surface. We show up every day, ready to engage and have fun with each other.

Requirements:
To be successful in this role, you will need to have at least 1 year of experience in quality assurance and/or regulatory affairs. You will also need to have a master's degree in healthcare, medical or life science, and excellent communication skills in English. Experience with working within or leading cross-functional projects is highly desirable.

We Offer:
In return for your hard work and dedication, we offer a competitive salary and a range of benefits, including professional development opportunities and a dynamic and supportive work environment.

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