Student Assistant (Quality Assurance and Regulatory Affairs)
Posted 3 hours 33 minutes ago by Radiobotics ApS
Join the exciting growth journey at Radiobotics and develop your skills in ISO standards, regulations, market registrations and much more in the health tech ecosystem, supporting the QA/RA objectives for Software as a Medical Device (SaMD) products revolutionizing Radiology through Machine Learning & AI
Share this open position
About the roleAre you currently looking for a part-time job in Aarhus? And are you considering a career within Quality Assurance or Regulatory Affairs? Join the exciting growth journey at Radiobotics and develop your skills in ISO standards, regulations, market registrations and much more in the health tech ecosystem, supporting the QA/RA objectives for Software as a Medical Device (SaMD) products revolutionizing Radiology through Machine Learning & AI.
Who you areYou probably have a background in molecular biology, health technology or other related field, and you are aiming at completing your degree within the next 2-3 years.
You are interested in developing yourself to become a QA/RA professional or a project manager within health tech. You are curious to learn how to develop and maintain a Quality Management (QMS) system in a regulated industry, and how to place medical device products in new markets.
On the personality side, you are structured, you can work both in groups and on your own, and you enjoy learning new stuff. And, you take responsibility for your tasks.
Tasks- Supporting the registration of products into new markets, including communication with relevant authorities
- Creating and maintaining QMS records related to CAPA, change control, customer complaints and training
- Reviewing and revising QMS procedures to ensure that they are efficient and effective
- Driving projects aimed at improving the efficiency of the quality and regulatory processes
- Familiarity with ISO13485, ISO 62304, ISO 82304 and/or Good Manufacturing Practice
- Experience working with medical device regulations
Learn how Radiobotics develops AI for radiology, bridging technology and clinical practice to support radiographers and improve patient care.
This Health AI Register product review and demo video features a user perspective from Ben Madden, Lead Reporting Radiographer at University Hospitals of Northamptonshire.