About Us

3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively and with superior care. We are a global market-leading provider of dental and audio technology for laboratories and clinics. Creating great innovation requires diverse teams. Our growing talent pool of over 1,500 employees spans 30+ nationalities and is energized by knowing that together, we contribute to a better world. 3Shapers are entrepreneurs, challengers and innovators… values that are at the heart of everything we do.

About The Role

We are looking for a systematic and structured employee to develop our Instruction for Use (IFU) documents for 3Shape hardware and software medical devices as well as coordinate documentation changes according to regulatory requirements. The IFU contains information provided by 3Shape to inform our customers of a medical device's intended purpose and proper use and of any precautions to be taken.

The work will be carried out in close collaboration with R&D, Regulatory Affairs, Graphics, Translation, Marketing teams in Denmark, Poland and Ukraine.

The ideal candidate should feel comfortable in an interdisciplinary and international environment.

Your key responsibilities will be to:

• Develop Instruction for Use documents for our medical devices according to regulatory requirements
• Identify when existing content requires updates and perform the changes
• Collaborating with Development team to define content
• Work together with colleagues from Marketing, Graphic and Translation teams
• Responsible for IFU lifecycle management
• Coordinate all the IFU changes according to our Design Change Procedure
• Plan and execute work assuring documents delivery according to agreed timelines
• Improve and standardize the processes around IFU planning and preparation
• Set up and coordinate IFU update strategy
  
  

To succeed in this position, you will need to:

The ideal candidate is hands-on, implementer with some years of experience with coordination of technical documentation and has:

• Experience with technical writing and coordination of technical documentation, e.g. from electrical equipment or software applications
• Experience in the development of medical devices is a big advantage
• B.Sc., M.Sc in Quality Engineering, Quality Management or related areas
• Strong verbal and writing skills at upper-intermediate level in English
• Excellent grammar, spelling and language usage skills with the ability to write simply and clearly
• Knowledge of Microsoft Office, InDesign and optional SolidWorks
• Strong interpersonal communication skills and enjoys collaborating across teams and countries
  
  

What We Offer

• Meaningful work that helps to change the future of dentistry
• Work in a unique professional, friendly and supportive environment
• Constant professional growth and development
• A healthy work-life balance
• Possibility of flexible remote work
• Comprehensive benefits incl. 24 working days of annual vacation; medical insurance; compensation of lunches; paid sick leaves and child sick leaves; maternity and paternity leaves etc
• Good working conditions in a comfortable office (not open space) near National Technical University “KPI”
• A parking lot with free spaces for employees
• Occasional business trips to Western Europe
• Opportunity to become a part of the success that 3Shape has created over the past 22 years.