Regulatory Affairs Lead

6 days ago


Århus, Århus Kommune, Denmark The HubDanske Bank Full time
About Radiobotics

We are a dynamic company driven by aspiration, curiosity, and playfulness. Our vision is to make routine X-rays of the musculoskeletal system augmented and first-line reported by our products. This will enable non-specialists to assist in reading radiology images, ensuring patients have access to immediate expert-level evaluation.

What We're Looking For

We're seeking an experienced QA/RA specialist who shares our values and passion for delivering high-quality medical devices. As a key member of our Clinical and Regulatory team, you will be responsible for ensuring our products meet the highest standards of quality and regulatory compliance.

Your 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 the risk analysis for new products, with support from our clinical and development team.
  • Reviewing and revising QMS procedures to ensure 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 You:

  • You have at least 1 year of experience within quality assurance and/or regulatory affairs, and you know that working with quality and regulatory processes within the medical device field is the right path for you.
  • You pay great attention to detail and your ability to structure your tasks efficiently means that you deliver on time.
  • The ideal candidate will furthermore have: a master's degree in healthcare, medical or life science; a positive can-do attitude with a thorough and structured mindset; excellent communication skills in English and experience with working within or leading cross-functional projects; knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR; experience with Software as a Medical Device.

Our Company Culture: At Radiobotics, we value integrity, transparency, and teamwork. We believe in empowering our employees to grow and develop in their careers, while maintaining a fun and supportive work environment.



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