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Join the exciting growth journey at Radiobotics and develop your skills in drafting research protocols and reports, ISO standards, regulations, market registrations and much more in the health tech ecosystem, supporting the Clinical and QA/RA objectives for Software as a Medical Device (SaMD) products revolutionising Radiology through Machine Learning & AI.
Job Responsibility:
Supporting the clinical team with drafting protocols and reports
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
Requirements:
Completed bachelor's degree
Aiming to complete degree within the next 2-3 years
Interest in developing within clinical affairs and QA/RA
Curious to learn how to develop and maintain a Quality Management System (QMS) in a regulated industry
Curious to learn how to place medical device products in new markets
Structured personality
Ability to work both in groups and independently
Enjoys learning new things
Takes responsibility for tasks
Nice to have:
Familiarity with ISO13485, ISO 62304, ISO 82304, Good Manufacturing Practice and/or Good Clinical Practice
Experience working with medical device regulations