At Radiobotics we are well on our way to product approval under MDR and are also looking to enter the US market. We are therefore looking to expand our QA/RA team with a regulatory affairs specialist.

Who we are

Radiobotics is an award-winning Danish healthtech startup, developing software as a medical device for radiology departments, aiding radiologists and radiographers interpreting musculoskeletal (msk) x-rays, with a focus on improving efficiency and diagnostic quality.

We are on a fast paced track with multiple upcoming approvals in both EU and USA. We are therefore looking to add another highly skilled colleague to the Regulatories Affairs/Clinical team.

We are a very R&D focused company, working within machine learning, deep learning and computer vision, and bringing our state-of-the-art technology to hospitals and clinics in an efficient, validated, and robust way.

With the technology we develop, we are paving the way, both in hospitals, but particularly also with the regulatory bodies. The answers are not always readily available for how to market the products we build and you will hence be expected to play a key role in navigating our technology in the regulations and guidelines that continuously are being published.

Who you are

You as the ideal applicant have experience with introducing and maintaining medical devices both in the EU and the USA, and preferably with software as a medical device. You feel comfortable applying as a specialist within Regulatory Affairs and can confidently set our strategy for both markets. But you can also help in activities related to maintaining and updating our QMS and in design control activities, and you have a good grasp of the relevant standards.

Since we are a small team, a new member will have to fit well into our group, with our informal mentality, and you have to be open to work on a wide range of tasks.

It is important that you have a structured approach and can navigate multiple projects at the same time - of course assisted by the rest of the team.

What we offer

We offer an exciting opportunity to join a fast paced company with strong momentum, high informal spirit, and 14 other happy colleagues. We work with multiple short deadlines, take pride in our work and in the opportunity we have to help both doctors, hospitals and patients using technology intelligently.

You will be joining a small team and will be reporting directly to the Co-founder & Chief Scientific Officer Martin Axelsen. Naturally, you’ll also collaborate across all departments of the company, particularly with our R&D department.

Specific responsibilities will include:

• Creating and coordinating the submission documentation for the devices we develop

• Maintaining existing registrations in multiple countries

• Assist management in prioritizing of registration activities based on strategy and market potentials

• Investigate and monitor requirements for new and existing markets

• Contributing to the development of technical documentation of new products

• Contributing to maintaining our QMS

• Participate in and co-lead the conduction of both internal and external audits

Where we are

We have a beautiful office in central Copenhagen where we work, have friday breakfast, delicious lunch, or take advantage of the surroundings and go for an ice cream break or an after-work beer/wine/drink.

We, however, also believe that sometimes we work better from home and that works for us too. We like to stick to normal business hours but we are also flexible in that sense, as long as we can be available to each other for meetings and through Slack when needed. 

Applications will be reviewed continuously, so please don't hesitate to apply.

Please attach your resume and a short motivational letter in pdf format.