Regulatory Affairs Specialist with Flair for Electronics

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? Then join us on our journey in changing the dental industry!

 Are you keen on working in a highly innovative environment where you will work with state-of-the-art dental technologies? The TRIOS scanning system used in the dental clinic consist of an advanced battery-powered scanner which takes 3D pictures of the patients teeth and transfers the data wirelessly to a mobile high-performance computer system to generate a full 3D model of the oral cavity. 

The Job

We seek a Regulatory Affairs Specialist with flair for electronics to help obtain and maintain regulatory approvals for our highly innovative intra oral dental scanners. This includes planning and executing medical device safety testing (IEC 60601), participation in the creating of the regulatory strategy and making national submissions.

You will get involved with the development team from the start of new product development, to get a deep insight into the development and registration of state of the advanced electronic medical devices, and make a global test strategy and participate in CB tests for CE marking. This could e.g. involve solving EMC issues or ensuring registration of wireless dongles in new countries and will involve close interaction with electronic R&D engineers. During registration work you will further be in direct contact with consultants and relevant notified and regulatory bodies globally.

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 and is based in downtown Copenhagen.

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

  • 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
  • Competitive salary and benefits
  • Healthcare package to keep you fit and well e.g. breakfast, fruit, snacks and lunch cooked by our private chef
  • Good work/life balance to keep you in tune with your interests
  • A great location in downtown Copenhagen, next to Kongens Nytorv

Need 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.

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

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. 

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

DK - Copenhagen

Holmens Kanal 7
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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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