RA specialist

3Shape offers a opportunity to work as a Regulatory Affairs Specialist where you will help obtain and maintain regulatory approvals for our highly innovative intra oral dental scanners.
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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. 

The Job

We seek a Regulatory Affairs Specialist to help obtain and maintain regulatory approvals for our highly innovative intra oral dental scanners. This includes developing regulatory strategies for new products, participation in the creation of technical files and making national submissions.

You will get involved with the development team from the start of new product development, 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. Furthermore, you will get involved in the MDR transition work.

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.

 The position is based in our TRIOS Lifecycle and Market Access group, which is a part of R&D.

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,
  • Experience with development or production of medical devices,
  • Experience with medical device regulations; MDD/MDR, 21 CFR 820, ISO 13485 and MDSAP,
  • Regulatory experience within the electronic medical device industry, e.g. preparation of a 510(k),
  • Knowledge of the regulatory landscape in e.g. China, Japan, Brazil and Korea.

We offer

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

 For more information

Please contact Head of TRIOS Lifecycle and Market Access - Lasse Leick, at +45 50 90 91 93 .

Application

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

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. 

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.

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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