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

As Regulatory Affairs Specialist you will drive obtaining and maintaining regulatory approvals for 3Shape 3D scanners and software medical devices as well as providing global registration support for the organization.

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:

• Conduction of regulatory activities linked to market expansion and maintenance
• Cooperation with external consultants for obtaining and maintaining country specific product approvals
• Close internal cooperation with especially RA colleagues and Development department
• Ensure alignment of regulatory strategy to business strategy across functional areas
• Answering questions from health regulatory bodies and from the company affiliates and agencies concerning regulatory authority interactions
• Communication with stakeholders regarding regulatory issues
• Involvement in various aspects of product development and international regulatory compliance. Furthermore, you will have to apply technical knowledge to review submitted documents and assessing whether they fit for purpose
• Manage transposition of international regulations into company product related requirements. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products including proofreading of labeling (IFU, labeling info)
• Ensure that the company's policies, procedures and operating guidelines conform to laws, regulations and industry practices. Develop & maintain regulatory knowledge of regulations worldwide
• Capable for understanding and handling questions related to the DHF’s
• Participate in communication with Competent Authorities with regard to vigilance cases, recalls and FSNs

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 regulatory affairs from medical device company
• Strong planning, cooperation and communication skills
• Familiar with Medical Device Directive, FDA QSR, ISO 13485, ISO 62304, Low Voltage Directive and EMC Directive etc
• Fluent (or very good) English with excellent verbal and written communication skills
• An interest in working in a multi-cultural environment with people who have various educational or work backgrounds
• Relevant theoretical background, preferably a university degree
• Passionate about new technology and knowledge

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.