3Shape A/S Business Support

Regulatory Affairs Specialist for software medical devices

 

Are you ready to boost your regulatory career in digital health? 3Shape offers a unique opportunity to bring truly novel dental technologies onto global markets.

You will become part of a fast-growing global company in the medical devices market and play a pivotal role in connecting development to regulatory authorities. If you are ready to continue your regulatory career within digital health working with software medical devices in a global setting, then 3Shape offers a unique opportunity to work as a Regulatory Affairs Specialist for software medical devices in the center of Kongens Nytorv, Copenhagen.

Our Team

You will join our Global Regulatory Affairs team based in 3Shape headquarters in Denmark. Currently, we are 13 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. As a member of the team, you should expect to quickly build up a broad network of strong relations, which will not only benefit your daily work, but also give you an edge at our legendary Friday bars.

The Regulatory Affairs department works closely together with many stakeholders across R&D, Product Management, sales offices around the globe as well as local external advisors and regulatory consultants.

The Job

You will be involved with the development team from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning of our software products. You will also be responsible for developing and maintaining the products´ regulatory strategy and for providing advice in the creation of the technical file. During the registration period, you will act as the direct point of contact with consultants and relevant notified and regulatory bodies globally.

Besides, you will be involved in our internal RA projects, such as the new Medical Device Regulation, MDSAP and process improvements.

Most importantly, you will have the possibility to influence your role according to your specialization and the career path you want to follow.

Your profile:

  • A Master’s degree within natural sciences, computer science, engineering or similar
  • Preferably 3 years of regulatory experience within the medical device industry. Knowing the regulatory landscape for software-based medical devices is considered an advantage (e.g. China and Japan)
  • Having a diverse work history, e.g. as a manager/developer of technical or software devices is considered an advantage
  • Having strong interpersonal skills and a positive attitude towards colleagues requiring regulatory guidance or challenging a regulatory approach
  • Proficient in English
  • Used to working both independently and in teams

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

Application:

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 recruitment 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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Reference No.:

NBH

Region:

  • Region Hovedstaden

Job type:

Regular

Working hours:

Full-time

Working days:

Day

Application deadline:

asap

Expected Start Date:

asap

Location:

Copenhagen

Contacts:

Company homepage:

http://www.3shape.com

Office address: