Medical Device Quality Assurance Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

A challenging opportunity has arisen at Radiobotics for a highly motivated and experienced QA/RA specialist to join our Clinical and Regulatory team. This role will be responsible for defining and delivering on our strategy to maintain superior product quality and place our products in new markets.

Main Responsibilities:

  1. Co-driving product release projects in collaboration with the development team
  2. Supporting other departments in design control
  3. Taking lead on risk analysis for new products, with support from the clinical and development team
  4. Reviewing and revising QMS procedures to ensure efficiency and effectiveness
  5. Assisting management in prioritizing regulatory approval activities based on strategy and market potential
  6. Creating and coordinating product submissions for developed devices (possibly supported by consultants)
  7. Training the company in QMS procedures
  8. Participating in audits, both internal and external

Requirements:

  • At least 1 year of experience in quality assurance and/or regulatory affairs
  • Knowledge of quality management systems and regulatory requirements within MDR, ISO 13485, and ideally 21 CFR
  • Experience with software as a medical device
  • Excellent communication skills in English and experience with cross-functional projects
  • A positive can-do attitude with a thorough and structured mindset
  • A master's degree in healthcare, medical, or life sciences


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