Medical Device Quality Assurance Specialist

2 weeks ago


Århus, Århus Kommune, Denmark The HubDanske Bank Full time

We are seeking a highly skilled and experienced Medical Device Quality Assurance Specialist to join our Clinical and Regulatory team at Radiobotics.

About the Role

As a Medical Device Quality Assurance Specialist, you will play a crucial role in ensuring the quality and compliance of our medical devices. You will be responsible for defining and delivering on our strategy to maintain superior product quality, leading on placing our products into new markets, and taking part in audits from notified bodies and authorities.

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 the 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.

This is an excellent opportunity to join a dynamic and innovative company that is committed to making a positive impact in the field of radiology.

You will have the chance to work with a talented team of professionals who are passionate about their work and dedicated to delivering high-quality results. Our company culture values integrity, transparency, and playfulness, and we strive to create a fun and engaging work environment.

The ideal candidate will have a minimum of 1 year of experience in quality assurance and/or regulatory affairs, preferably within the medical device industry. They will possess a master's degree in healthcare, medical or life science, and have excellent communication skills in English.

A salary range of $80,000 - $120,000 per year is expected for this role, commensurate with experience. We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.



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