Ambitious Regulatory Affairs Specialist

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

Things move fast at 3Shape as 3Shape is one of Denmark’s fastest growing companies, just awarded as Børsen’s Gazelle #1. 3Shape offers an international atmosphere with +30 nationalities working in the Copenhagen headquarters. Globally, 3Shape employs more than 900 – with 1/3 employed within R&D.

3Shape specializes in developing 3D scanning and software solutions that enables dental and hearing professionals to treat more people, more effectively and with improved care. The company is referred to as "The Google of the CAD/CAM Industry" and has recently been dubbed the "Apple" of dentistry. 3Shape is privately-owned which enables us to make fast decisions.

As a Regulatory Affairs Specialist, you will join our Global Regulatory Affairs team based in Copenhagen. We are currently a team of 4 Regulatory Affairs Specialists and 1 Scientific Manager with diverse backgrounds. You will interact with a wide range of stakeholders and especially with R&D, Product Management, global sales offices and external consultants worldwide.

Your Role

The main purpose of this position is to obtain and maintain regulatory approvals for our dental scanners and/or software portfolio, and provide registration support globally. You will be a member of 3Shape´s product development teams and contribute with your regulatory expertise. In addition, there are also several RA projects you will be involved in or lead (e.g. new Medical Device Regulation, regulatory strategies, process improvements). 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 Qualifications

You have a Master’s degree within natural sciences, engineering or similar. You have min. 3 years of regulatory experience within the medical device industry. Knowing the regulatory landscape for active and/or software-based medical devices, this will be considered as an advantage. Having strong interpersonal skills, you have a positive attitude towards colleagues requiring regulatory guidance or challenge a regulatory approach. Finally, you are proficient in English and are used to working both independently and in teams.

We offer

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

We interview continuously, therefore please attach your cover letter and application today by clicking on "send application". We look forward to hearing from you, and for further details you are welcome to contact Antje Marquardsen.

Application deadline

06/30/2017

Location

Copenhagen

Contacts

Antje Marquardsen
Telephone: +45 24 94 14 49

Send application

http://www.3shape.com

About Us

3Shape A/S is a Danish company specializing in the development and marketing of 3D scanners and CAD/CAM software solutions for the use, creation, processing, analysis and management of high quality 3D data.

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 fulfill 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.