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Quality Assurance and Regulatory Expert

2 weeks ago

Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

At Radiobotics, we are looking for a highly skilled Quality Assurance and Regulatory Affairs specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a crucial role in defining and delivering our strategy to maintain superior product quality.

Main 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 efficiency and effectiveness
  • Assisting management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating product submissions for developed devices (possibly supported by consultants)
  • Training 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, with a deep understanding of quality and regulatory processes within the medical device field.
  • You possess excellent communication skills in English and experience working within or leading cross-functional projects.
  • Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485 is essential, with experience with Software as a Medical Device being a plus.

We Offer

  • A dynamic and collaborative work environment with opportunities for growth and professional development.
  • The chance to be part of a mission-driven organization that values integrity, transparency, and innovation.
  • A competitive salary and benefits package.