At Radiobotics we are well on our way to product approval in the US according to FDA 510(k) and are looking to launch more products in the US. We are therefore looking to expand our QA/RA team with a regulatory affairs manager with FDA submission experience to lead our future EU and US submissions.
Radiobotics is a multiple award-winning Danish health tech startup, developing software as a medical device for radiology and orthopedic departments and, aiding radiologists, radiographers, and orthopedic surgeons in 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 the EU and USA. We are therefore looking to add a highly skilled manager to the RA/QA 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. Our QMS is certified according to ISO 13485 and our first product was CE marked as a class IIa device according to MDR.
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.
You as the ideal applicant have experience with introducing and maintaining medical devices under FDA U.S. regulations and preferably proven experience with software as a medical device. You feel comfortable applying as a manager within Regulatory Affairs and can confidently set our strategy for the US market. 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 such as ISO 13485, ISO 14971, and ISO 62304. 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.
Specific responsibilities will include:
Leading the QA/RA team
Leading the 510(k) submissions and working with supporting consultants,
Creating and coordinating the 510(k) submissions for the devices we develop,
Assist management in prioritizing regulatory approval activities based on strategy and market potentials,
Investigate and monitor requirements for new and existing markets,
Oversee and contribute to the development of technical documentation of new devices,
Oversee and contribute to the maintenance of our QMS,
Participate in and lead both internal and external audits.
We offer an exciting opportunity to join a fast-paced company with strong momentum, a high informal spirit, and 16 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 of two, which you will be leading. You 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.
We are located in Copenhagen, Denmark but the location is not important to us if you have the right skills you can be working from anywhere.
Applications will be reviewed continuously, so please don't hesitate to apply.
Please attach your resume and a short motivational letter in pdf format.
This job comes with several perks and benefits
Time is precious. Make it count. Morning person or night owl, this job is for you.
Get your caffeine fix to get you started and keep you going.
Social gatherings and games; hang out with your colleagues.
Peckish after lunch? We got your back with soft drinks, treats and fruit.
Friday is something special, let's enjoy a beer together.
Easy access and treehugger friendly workplace.