Student Assistant (Quality Assurance and Regulatory Affairs)
Are 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 SaMD products revolutionizing Radiology through Machine Learning & AI.
Who we are
Radiobotics is a multiple award-winning Danish health tech startup, developing software as a medical device for radiology, orthopedic and emergency departments and, aiding healthcare professionals in interpreting x-rays, with a focus on improving efficiency and diagnostic quality. We are QMS certified according to ISO 13485 and our first product has been cleared for market in the U.S. via a 510(k) process and was one of the first products to receive a CE marked as a class IIa device according to the European Medical Device Regulation. Several development projects are in the pipeline, and we are also looking into expansion to new markets in near future.
Who you are
You probably have a background in molecular biology, health technology or other related field, and you are in the final semester of a Bachelor's degree or have just started a Master's degree. 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:
- Assisting the R&D team and the QA team in updating and reviewing the Technical Documentation during product development and maintenance
- Reviewing and revising QMS procedures to ensure that they are efficient and effective
- Support internal and external audits
- Establishing strategies to launch products into new markets, including communication with relevant authorities
- Creating and maintaining QMS records related to CAPA, change control, customer complaints and training
Nice to have:
- Experience with ISO13485, Good Manufacturing Practice
- Experience working with medical device regulations
We encourage all interested candidates, regardless of age, gender, sexual orientation, race, nationality, disability, religion, or ethnic affiliation to apply for the position.
Start date:
As soon as possible. For more information or questions please contact us at hege@radiobotics.com.
Please write in your application that you've seen the job at Jobfinder.
