Product Regulatory Affairs Expert

5 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

We are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other. Our vision is to solve the global need for radiologists while ensuring every patient receives expert-level care.

As a Quality Management System Professional, you will be responsible for defining and delivering on our strategy to maintain superior product quality. You will work closely with our Clinical and Regulatory team to ensure that our products meet the highest standards of quality and safety.

Your main responsibilities will include:

  1. Developing and implementing QMS procedures to ensure compliance with regulatory requirements
  2. Conducting risk analyses and developing mitigation strategies
  3. Collaborating with cross-functional teams to ensure seamless product development and launch
  4. Providing training and support to ensure that all employees understand QMS procedures
  5. Participating in audits and assessments to ensure ongoing compliance

The ideal candidate will have a strong background in quality assurance and regulatory affairs, excellent communication skills, and the ability to work effectively in a fast-paced environment.



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