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Join 3shape as Senior Regulatory Affairs Specialist!
Let’s change dentistry together!
About the team and role
Are you a software savvy regulatory expert? Then come join a team on the rise. Our Regulatory Affairs Software Team is looking for a colleague to support the development of a new AI diagnostic device and setting the right regulatory strategies.
As Senior Regulatory Affairs Specialist you will play a key role in ensuring that regulatory requirements are in place for our new innovative medical device software solution. You will be involved in the development project, where your profound regulatory expertise will be needed as crucial input for the development and market release planning and registration of our software devices.
You will join our Global Regulatory Affairs Department based in 3Shape headquarters in Denmark. Currently, we are 27 people with diverse backgrounds and nationalities at the Danish office in the middle of Copenhagen. 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.
A Master’s degree within natural sciences, computer science, engineering or similar
Preferably 8-10 years of regulatory experience from the medical device or pharmaceutical industries
Experience with SaMD, submissions e.g. 510(k), De Novo and MDR STED and relevant standards ISO 14971, IEC 62304 etc.
Global mindset and experience with work relations in different cultures
Strong verbal and written communication skills in English
“The RA SW team is simply a great place to be! We work hard but play and laugh equally hard at the same time - and very much enjoy hanging out together also after working hours. More than that, the team has proven to be a very central hub with close stakeholder-relations all over the organization and it makes every day interesting and challenging in the most positive way.”
Ida Søholm, Senior Project Manager, R&D Regulatory Affairs
3Shape: An exciting, visionary, and international place to work
Join one of the most exciting Danish tech companies in the medical device industry and make an impact. With us you will be able to work on solutions used by thousands of dental professionals worldwide.
A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues - we are more than 40 nationalities in our DK based office
An attractive healthcare package to keep you fit and well.
Breakfast every day, and delicious and healthy lunch cooked by our private chefs.
We provide a great social work environment with many optional activities and social clubs, ranging from wine & beer, board games, running to bicycle clubs.
Good work/life balance e.g., work from home policy
Attractive offices and R&D lab spaces in downtown Copenhagen close to Kgs. Nytorv, Nyhavn, and the Copenhagen Canals.
Get in touch now!
If you are interested in this exciting opportunity, apply already today. We will review the applications continuously.
We encourage all relevant applicants to apply. We are committed to celebrate human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.
3Shape started with a simple idea - to make 3D scanning better. Today 3Shape has 2,000+ employees globally, with 500 employees in Copenhagen HQ. With the help of dental professionals and amazing colleagues we create award-winning scanning solutions. Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook and Instagram. Visit our website If you want to read more about our company, recruitment process, or why 3Shape is a great place to work.
Life at 3Shape is great! We bring passion and talent to work every day to innovate for superior patient care. 3Shape is built on a culture of thinking differently and being innovative when solving challenges. We embrace new ways to exchange ideas with colleagues across departments and think and work in an agile way. Experience the everyday #lifeat3Shape across the globe on Facebook.
3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively and with superior care. We are a global market-leading provider of dental and audio technology for laboratories and clinics.
Our growing talent pool of over 2,000 employees spans 50+ nationalities and is energized by knowing that together, we contribute to a better world.
Two graduate students founded 3Shape in Denmark’s capital, Copenhagen in the year 2000. Today, 3Shape employees serve customers in over 100 countries. As a privately-owned company, decisions are made fast, and we remain agile.
3Shape is headquartered in Copenhagen, with development teams in Denmark, Ukraine and Macedonia with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.
Regulatory Affairs·DK - Copenhagen
Senior Regulatory Affairs Specialist
Join 3shape as Senior Regulatory Affairs Specialist!
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