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Medical Device Quality Assurance Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Job Description:

We are seeking an experienced Quality Assurance/Regulatory Affairs Specialist to join our Clinical and Regulatory team at Radiobotics ApS.

The ideal candidate will have a strong background in quality management systems, regulatory requirements, and software as a medical device. As a key member of our team, you will be responsible for ensuring the highest level of product quality, developing and implementing QMS procedures, and collaborating with cross-functional teams.

Main Responsibilities:

  1. Drive product release projects in collaboration with the development team
  2. Support design control activities across departments
  3. Lead risk analysis for new products with support from clinical and development teams
  4. Review and revise QMS procedures for efficiency and effectiveness
  5. Assist management in prioritizing regulatory approval activities based on strategy and market potential
  6. Create and coordinate product submissions for developed devices
  7. Train the company in QMS procedures
  8. Participate in internal and external audits

Requirements:

  • At least 1 year of experience in quality assurance and/or regulatory affairs
  • Strong knowledge of quality management systems and regulatory requirements within MDR and ISO 13485
  • Excellent communication skills in English
  • Ability to work independently and as part of a cross-functional team