Medical Device Quality Assurance Specialist

4 weeks ago


Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance/Regulatory Affairs professional to join our Clinical and Regulatory team. As a key member of our team, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities
  • Develop and implement quality management systems and processes to ensure compliance with regulatory requirements
  • Conduct risk assessments and develop mitigation strategies to ensure product safety and efficacy
  • Collaborate with cross-functional teams to ensure seamless product development and launch
  • Review and revise quality procedures to ensure efficiency and effectiveness
  • Provide training and support to ensure compliance with quality and regulatory requirements
  • Participate in audits and inspections to ensure compliance with regulatory requirements
Requirements
  • Minimum 1 year experience in quality assurance and/or regulatory affairs
  • Master's degree in healthcare, medical or life science
  • Excellent communication and interpersonal skills
  • Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485
  • Experience with software as a medical device
About Us

At Radiobotics, we are driven by a passion for innovation and a commitment to excellence. We are seeking a talented and motivated individual to join our team and contribute to our mission to solve the global need for radiologists while ensuring every patient receives expert-level care.



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