Senior Regulatory Affairs Specialist for Health Tech Start-up

Radiobotics Copenhagen Full-time
Salary Competitive
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 senior regulatory affairs specialist.

Who we are

Radiobotics is an award winning Danish health tech startup, creating 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 QA/RA 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.

You will be joining our small QA/Clinical team and will be answering directly to the Chief Scientific Officer. But we have very close collaboration across all departments of the company, particularly R&D department.

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 for a senior RA specialist position (probably you have +5 years experience) 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 feel at home in 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.

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.

What we offer

We offer an exciting opportunity to join a fast paced company with strong momentum, high informal spirit, and 12 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.

Applications are welcome through July 26, but will be reviewed continuously, so please don't hesitate to apply.

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

For more information or questions please contact us at or phone number 26146184

Perks and benefits

This job comes with several perks and benefits

Flexible working hours
Flexible working hours

Time is precious. Make it count. Morning person or night owl, this job is for you.

Free coffee / tea
Free coffee / tea

Get your caffeine fix to get you started and keep you going.

Social gatherings
Social gatherings

Social gatherings and games; hang out with your colleagues.

Free office snacks
Free office snacks

Peckish after lunch? We got your back with soft drinks, treats and fruit.

Free friday beers
Free friday beers

Friday is something special, let's enjoy a beer together.

Near public transit
Near public transit

Easy access and treehugger friendly workplace.

Working at

In Radiobotics we are developing stellar machine learning algorithms, supporting doctors in analysing medical images, and making the right decisions. We are collaborating with hospitals across EU and the US, ensuring immediate clinical impact, eventually benefitting patients. We are an award winning start-up looking to expand our team, so please get in touch, in you are interested in hearing more about opportunities.

Read more about Radiobotics

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