Regulatory Affairs Specialist for electronic medical device

Are you ready to continue your regulatory career within digital health care working with 3D medical scanners in a global setting? 3Shape offers a unique opportunity to work as a Regulatory Affairs Specialist where you will work with state-of-the-art dental technologies.

Your Role

We seek a Hardware Regulatory Affairs Specialist to join our Regulatory Affairs team based in Copenhagen.  Your main role is participating in obtaining and maintaining regulatory approvals for our highly innovative intra oral dental scanners to enable global market access.

You will be a member of the product development team to ensure that both development and regulatory considerations are included in market release and certification planning. Your role is e.g. to develop and maintain the products´ regulatory strategy, participate in the creation of the technical file and take responsibility for national submissions.

As 3Shape often introduces new products, you will get involved with the development team from the start, getting a deep insight into the development and registration of electronic medical devices. During registration work you will be in direct contact with consultants and relevant notified and regulatory bodies globally. Hence the work will take you travelling for 10-20 days/year.

In order to work at your best, you will have the possibility to influence the content of your role according to your specialization and the career path you want to follow.

Your profile:

The ideal candidate is a hands-on, implementer who enjoys working in a cross functional team, and further has most of the following qualifications:

  • A Master’s degree within engineering, natural sciences or similar
  • Ability to find the fastest path to market access for our products
  • Regulatory experience within the electronic medical device industry.
  • Experience with CE marking, FDA and 510(K)
  • Experience with development or production of electronic medical devices
  • Knowledge of the regulatory landscape in e.g. China, Japan, Brazil and Korea

 We offer:

  • A professional challenge in a highly dynamic globally oriented business environment
  • An opportunity to become part of a successful, enthusiastic, international development team in an informal workplace
  • A competitive salary and benefits
  • A great location in downtown Copenhagen

Application

Applications will be processed continuously until 13 December so do not hesitate to apply for this exciting opportunity at one of Denmark’s most successful and fastest growing MedTech companies.

Read more about working at 3Shape at www.3shape.com/Corporate/Careers

Application deadline

asap

Location

Copenhagen

Contacts

Antje Marquardsen
Mobile: +45 24 94 14 49

Send application

http://www.3shape.com

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 1,500 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. www.3shape.com

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.