Student Assistant (Quality Assurance and Regulatory Affairs)

Radiobotics Aarhus Student

Salary Competitive

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 Software as a Medical Device (SaMD) products revolutionizing Radiology through Machine Learning & AI.

Who we are
Radiobotics is a multiple award-winning Danish health tech startup, developing SaMD 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 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.

Nice to have

• Familiarity with ISO13485, ISO 62304, ISO 82304 and/or 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

Perks and benefits
This job comes with several perks and benefits

Flexible working hours
Free coffee / tea
Social gatherings
Free office snacks
Free friday beers
Near public transit