3Shape A/S Scanner Development

Head of Regulatory Affairs

Currently, we are 9 Regulatory Affairs Specialists/Coordinators, 6 Product Quality Managers/Engineers and 3 Scientific Managers with diverse backgrounds. In addition, 3 Regulatory Affairs Specialists are located in Brazil, Korea and Japan, respectively. Further colleagues will join the team in 2019.

You will interact with a wide range of stakeholders, especially R&D, Product Management, global sales offices and external consultants. You will help develop the future of disruptive health tech in collaboration with the entire organization and enable people across the world to enjoy better lives. 

The job:

Reporting to the Director of Regulatory Affairs, you will be leading and developing your team of Regulatory Affairs Specialists and Product Quality Managers in order to execute our global regulatory strategies supporting our strategic focus area “Regulatory as market access enabler” as well as drive design control activities in close collaboration with our R&D organization. You will also take part in cross-organizational projects (e.g. new Medical Device Regulation, MDSAP, labeling). To do so, you set a clear direction, motivate your team to deliver and enable the individual development of employees.

Your profile:

You thrive in a role that requires a high degree of organization and collaboration because you are proactive by nature and take a highly structured approach to your work. At the same time, you are flexible and know how to reach agreements through dialogue and compromise. 

Furthermore, you have:

  • Minimum 5 years´ experience from the medical device industry within regulatory affairs and/or design control. preferably with active and/or stand-alone software devices.
  • Very good knowledge of global legislation, systems and procedures applicable to the medical device industry.
  • Leadership experience (people management or project management)
  • A good understanding of complex technical issues
  • Solid communication skills and you speak and write English fluently.

We offer:

  • A professional challenge in a highly dynamic globally oriented business environment
  • An opportunity to become part of a successful, enthusiastic, international team in an informal workplace
  • A competitive salary and benefits
  • A great location in downtown Copenhagen

In this video, Jesper Lomborg Manigoff, vice president for R&D Software Development, explains how trust and empowerment are key to our teams:


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/Careers

To all agencies: Please, no phone calls or emails to any employee of 3Shape about this opening. All resumes submitted by search firms/employment agencies to any employee at 3Shape via-email, the internet or in any form and/or method will be deemed the sole property of 3Shape, unless such search firms/employment agencies were engaged by 3Shape for this position and a valid agreement with 3Shape is in place. In the event a candidate who was submitted outside of the 3Shape agency engagement process is hired, no fee or payment of any kind will be paid.

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Antje Marquardsen

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