Regulatory Affairs Specialists

Are you ready to continue your regulatory career within digital health working with 3D scanners as well as software medical devices in a global setting?
Then 3Shape offers a unique opportunity to work as our new Regulatory Affairs Specialist in the center of Copenhagen at Kongens Nytorv. This opportunity will help you develop within future disruptive health technologies together with the entire organization and with exposure to senior management.

About the department

As a Regulatory Affairs Specialist, you will join our Global Regulatory Affairs team based in Copenhagen. We are currently a team of nine Regulatory Affairs Specialists/Coordinators and one Scientific Manager with diverse backgrounds. Six additional colleagues are expected to join the team in 2018. You will interact with a wide range of stakeholders and especially with R&D, Product Management, Global Sales offices, and external consultants worldwide.

The Job

The main purpose of this position is to obtain and maintain regulatory approvals for our highly innovative dental scanners and/or software products to ensure their registration globally. You will be a member of the product development team and contribute with your regulatory expertise, e.g., advice in the creation of the technical file and develop and maintain the products´ regulatory strategy.
As 3Shape often introduce new products, you can have the opportunity of being involved from the very first meetings about a new product, getting a deep insight of the processes associated with the product launch of a medical device.  In addition, there are also several internal RA projects you will be involved in, e.g., the new Medical Device Regulation, or process improvements. You will have the opportunity to influence the content of your role according to your specialization and the career path you want to follow.

Your profile

  • A Master’s degree within natural sciences, engineering, or similar
  • Minimum 3 years of regulatory experience within the medical device industry. Knowing the regulatory landscape for active and/or software-based medical devices is considered an advantage
  • Having a diverse work history, e.g., as a developer of technical or software devices is considered an advantage
  • Having strong interpersonal skills and a positive attitude towards colleagues requiring regulatory guidance or who challenge a regulatory approach
  • Proficient in English
  • Experience with working both independently and in teams

We offer

  • A professional challenge in a highly dynamic and globally oriented business environment
  • The chance to influence the future of an expanding company
  • An opportunity to become part of an enthusiastic and international team in an informal workplace
  • A competitive salary and benefits
  • Nice offices in downtown Copenhagen


Apply for this position already today and upload your transcripts together with your CV and cover letter as we interview continuously. Please apply via the link “send application”. We look forward to hearing from you!

Read more about working at 3Shape at

Application deadline





Antje Marquardsen
Telephone: +45 24 94 14 49

Send application

About Us

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs.
Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,200 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively.

Working at 3Shape

Become part of an international success, financially as well as product wise. As an employee, you have plenty of room to both make a difference and fulfil personal ambitions in a very knowledge intensive and challenging environment.

3Shape Technology

Through the relentless drive for new digital innovation by 3Shape, we claim to be the most extensive and versatile CAD/CAM system on the market.

3Shape - a Global Company

3Shape is headquartered in Copenhagen, with development teams in Denmark as well as in the Ukraine and with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.

Our People

Employing and developing the right people is an important key to 3Shape's success. We want to be the best within our business, an ambition which has created a true fighting spirit throughout the company - with lots of commitment and courage, and a professional attitude towards business.