Medical Device Quality Assurance Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

We are seeking a highly skilled and experienced QA/RA specialist to join our Clinical and Regulatory team at Radiobotics. The successful candidate will play a crucial role in maintaining superior product quality and driving our strategy for placing products on new markets.

As a QA/RA specialist, you will become an expert in all corners of our Quality Management System, engaged in all stages of product development and ensuring our internal quality processes are well-oiled. You will be responsible for co-driving product release projects, supporting other departments in design control, and taking lead on risk analysis for new products.

Main Responsibilities:

  • Co-drive product release projects in collaboration with the project manager from the development team
  • Support other departments in design control
  • Take lead on risk analysis for new products, with support from our clinical and development team
  • Review and revise QMS procedures to ensure they are efficient and effective
  • Assist management in prioritizing regulatory approval activities based on strategy and market potentials
  • Create and coordinate product submissions for devices we develop (possibly supported by consultants)
  • Train the company in QMS procedures
  • Participate in audits, both internal and external

Requirements:

  • At least 1 year experience within quality assurance and/or regulatory affairs, and knowledge that working with quality and regulatory processes within the medical device field is the right path
  • 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


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