Senior Regulatory Affairs Specialist

About the team and role

As Senior Regulatory Affairs Specialist, you will play a key role in ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices. You will be involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices.

You will join our Global Regulatory & Scientific Affairs Department based in 3Shape headquarters in Denmark. Currently, we are 24 people with diverse backgrounds and nationalities at the Danish office in the city centre of Copenhagen. Together with our awesome team in Ukraine, and regulatory colleagues in China, South Korea and Japan we ensure global device registrations. Emphasizing empowerment and taking ownership are key aspects of our culture. Having fun as well. Going to work makes us smile!

We enjoy the team spirit and create great results together with our various stakeholders. Regulatory Affairs works closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants. We have great collaboration with the organization and regulatory is seen as a business enabling function. We are also active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks.

Qualifications

• Master’s degree within natural sciences, computer science, engineering or similar.

• 5-10+ years in regulatory affairs (preferably both software and hardware medical devices).

• Global regulatory market experience (e.g. EU, UK, Switzerland and MDSAP)

• Demonstrated experience applying and interpreting relevant guidance and standards across software and hardware medical devices, including: IEC 60601 series, ISO 14971, IEC 62304, IEC 82304.

• Strong knowledge of cybersecurity and the evolving regulations for digital health and AI/ML devices.

• Adaptable and open to change and adjustments in agile work environments

• Global mindset and experience with work relations in different cultures

Join us in shaping a company culture that makes Monday mornings worth it

We are an exciting, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities in our DK office who all contribute to an awesome company culture. We partake in social clubs, monthly Friday social activities, as well as various in-team activities. If that’s not enough, then add on:

• An attractive healthcare package to keep you fit and well

• Breakfast every day, and a delicious and healthy lunch cooked by our private chefs

• Good work/life balance e.g., work from home policy for up to 2 days per week

• Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv

• A joint purpose: to enable dentists to provide superior patient care to every patient, every time

We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.