Regulatory Affairs Specialist

Do you want to enhance your regulatory career in digital health? Come join 3Shape and be part of one of the most successful and fastest growing MedTech companies in Denmark!
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3Shape is a global leader in digitizing dental treatments and specializes in developing 3D scanners and CAD/CAM software solutions that benefit both patients and dentists alike. Now, you have an opportunity to work in the center of Copenhagen and join a diverse workforce of over 1600 employees spanning 30+ nationalities.

Innovation is a central part of ‘our DNA’ which fosters a culture of thinking differently in 3Shape. Emphasizing empowerment and taking ownership are key aspects of our culture. We are no longer a start-up, but we take pride in continuing to think like one – together we embrace new ways to exchange ideas and develop unprecedented innovations.

About the department

As Regulatory Affairs Specialist you will play a pivotal role in ensuring that regulatory requirements are fulfilled in order to place our innovative digital health solutions on global markets.

You will join our Global Regulatory Affairs department based in 3Shape headquarters in Denmark. Currently, we are 21 people with diverse backgrounds and nationalities at the Danish office in Copenhagen at Kongens Nytorv. Further, we have Regulatory Affairs colleagues located in China, Korea, Japan and Ukraine and more associates will join Global Regulatory Affairs in 2021.

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.

Your role

As our new Regulatory Affairs Specialist you will become part of the Software team in Regulatory Affairs, in R&D. 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 of our software products. You will also be responsible for developing and maintaining the regulatory strategy for our software solutions. During the registration period, you will act as the direct point of contact with consultants and relevant notified and regulatory bodies globally.  You will also be involved in our internal projects, such as Regulatory Intelligence, process improvements and creation of procedures in the regulatory area supporting software related topics.

Your profile

  • A Master’s degree within natural sciences, computer science, engineering or similar
  • Preferably 4 years of regulatory experience within the medical device industry
  • Knowing the regulatory requirements for medical device software (e.g. EU, US, China and preferably also other markets)
  • Used to working both independently and in teams and have cross functional interactions
  • Adaptable and open to change and adjustments in agile work environments
  • Global mindset and experience with work relations in different cultures
  • Strong verbal and written communication skills in English

We offer

  • An attractive, international workplace in the center of Copenhagen, with highly skilled and committed colleagues in an informal work environment
  • A unique opportunity to specialize in the regulatory field of software and digital health - aspects of high importance in the future of medical devices
  • A company culture built on mutual respect and openness, strong team spirit and high performance
  • Healthcare package to keep you fit and well, and delicious and healthy lunch cooked by our private chef
  • Work/life balance to keep you in tune with your interests Opportunity to become part of the success that 3Shape has created over the past 20 years

If you want to read more about our company, our mission or simply find out why 3Shape is a great place to work take a look at our website!

Application

If you are interested in this exciting opportunity, apply already today and upload your motivational cover letter and resume. We will review the applications continuously.

 

We encourage all relevant applicants to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status. All qualified applicants will be given equal opportunity and the selection is based on job-related factors.

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. Now, twenty years later, 3Shape is 1,600+ 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 Facebook.

Or, know someone who would be a perfect fit? Let them know!

DK - Copenhagen

Holmens Kanal 7
1060 København Directions View page

Our biggest assets are our people and culture 💗

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. 

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