Medical Device Quality Assurance Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Company Overview:

Radiobotics ApS is a company on a mission to solve the global need for radiologists while ensuring every patient receives expert-level care.

We strive to learn what happens beyond the surface and show up every day, ready to engage and have fun with each other. This is us. We are Radiobotics.

Salary:

The estimated salary for this position is between 80,000 - 120,000 DKK per year, depending on experience and qualifications.

Job Description:

As a QA/RA Specialist in Radiobotics, you will become an expert in all corners of our Quality Management System. You will be engaged in all stages of product development and help define the structure of technical documentation, as well as ensure our internal quality processes are well-oiled.

You will play a central role in placing products into new markets, be pivotal in maintaining our products in existing markets, and take part in audits from notified bodies and authorities.

Main Tasks:

  • 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 they are efficient and effective
  • Assisting management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating product submissions for the devices we develop (possibly supported by consultants)
  • Training the company in QMS procedures
  • Participating in audits, both internal and external

Required Skills and Qualifications:

  • At least 1 year of experience within quality assurance and/or regulatory affairs
  • 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

Benefits:

  • Flexible working hours
  • Free coffee/tea
  • Social gatherings
  • Free office snacks
  • Free Friday beers
  • Near public transit


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