Medical Device Quality Assurance Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Job Title: Medical Device Quality Assurance Specialist

Job Summary: We are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team at Radiobotics. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities:

  • Develop and implement quality management systems to ensure compliance with regulatory requirements
  • Conduct risk assessments and develop mitigation strategies to ensure patient safety
  • Collaborate with cross-functional teams to ensure quality and regulatory compliance throughout the product development lifecycle
  • Develop and maintain technical documentation, including user manuals and instruction guides
  • Participate in audits and inspections to ensure compliance with regulatory requirements

Requirements:

  • Master's degree in a relevant field, such as healthcare, medical science, or life science
  • Minimum 1 year of experience in quality assurance and/or regulatory affairs
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
  • Knowledge of quality management systems and regulatory requirements, including MDR and ISO 13485

About Radiobotics:

Radiobotics is a dynamic and innovative company that is dedicated to solving the global need for radiologists. We are committed to ensuring that every patient receives expert-level care, and we are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team.



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