Regulatory Affairs Coordinator

3Shape´s Global Regulatory Affairs department is looking for a Regulatory Affairs Coordinator at our head office at Kongens Nytorv 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 our global sales offices, resellers and external consultants worldwide.

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 people – 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.

Your Role

Job responsibilities include:

  • Legalisation of certificates and documents
    • Providing responses to inquiries from internal and external partners
    • Archiving of documents
    • Support the RA Specialist in compiling product submissions
    • Establish country specific overviews regarding documentation requirements
    • Daily administrative support

 

Your Qualifications

  • Educated to degree level in engineering, health sciences or related field
  • Regulatory experience of working in the medical device or pharmaceutical industry
  • Excellent communication and IT skills, with an eye for details
  • Proficient in English

As a person you have a positive attitude towards colleagues and enjoy working in a cross-functional environment with different stakeholders and partners, both internally and externally. requiring regulatory guidance or challenge a regulatory approach Finally, you 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 a enthusiastic and international teams in an informal workplace
  • Nice offices in downtown Copenhagen

Application

Apply for this position already today (latest by the 15th June 2017) by uploading your transcripts, CV and cover letter as we interview continuously to "send application".

Application deadline

06/15/2017

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.