2 Regulatory Affairs Specialists

3Shape is looking for two talented regulatory affairs specialists – one working with software medical devices and one working with active medical devices.

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Regulatory Affairs Specialist, Software

Are you ready to continue your regulatory career in digital health in a global setting working within dentistry, specifically software medical devices?

3Shape offers a unique opportunity to work as Software Regulatory Affairs Specialist in the heart of Copenhagen. Here you will work with state-of-the-art dental technologies together with all of 3Shape including senior management.

The Job

The main purpose of this position is to obtain and maintain regulatory approvals for our innovative software medical devices to enable market access globally.

You will be a member of the product development team, where your regulatory expertise is needed as crucial input for the development and market release planning. Your role is e.g. to develop and maintain the products´ regulatory strategy and advice in the creation of the technical file.

As 3Shape often introduces new products, you will have the opportunity to be involved with the development team from the start, getting a deep insight into the processes associated with a medical device product launch. During registration work, you will be in direct contact with consultants and relevant notified and regulatory bodies globally.

In addition, there are also internal RA projects you will be involved in, e.g. the new Medical Device Regulation, MDSAP and process improvements.

In order to work at your best, you will have the possibility to influence the content of 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

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Regulatory Affairs Specialist, Hardware

Are you ready to continue your regulatory career within digital health working with 3D medical scanners in a global setting? 

3Shape offers a unique opportunity to work as a Regulatory Affairs Specialist in the heart of Copenhagen. Here you will work with state-of-the-art dental technologies together with all of 3Shape including senior management.

The Job

The main purpose of this position is to obtain and maintain regulatory approvals for our highly innovative dental and CBCT scanners to enable market access globally. 

You will be a member of the product development team, where your regulatory expertise is needed as crucial input for the development and market release planning. Your role is e.g. to develop and maintain the products´ regulatory strategy and advice in the creation of the technical file. 

As 3Shape often introduces new products, you will have the opportunity to be involved with the development team from the start, getting a deep insight into the processes associated with a medical device product launch. During registration work, you will be in direct contact with consultants and relevant notified and regulatory bodies globally.

In addition, there are also several internal RA projects you will be involved in, e.g. the new Medical Device Regulation, MDSAP and process improvements.

In order to work at your best, you will have the possibility to influence the content of your role according to your specialization and the career path you want to follow.

Your Profile

  • A Master’s degree within engineering, natural sciences or similar
  • Preferably 3 years of regulatory experience within the medical device industry. Knowing the regulatory landscape for active medical devices is considered an advantage (e.g. China, Japan, Brazil and Korea)
  • Having a diverse work history, e.g. as a developer of technical/active medical 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

 

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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 fulfil personal ambitions in a very knowledge-intensive and challenging environment.

Our Team

As a Regulatory Affairs Specialist, you will join our Global Regulatory Affairs team based in Copenhagen. We are currently a team of 12 Regulatory Affairs Specialists/Coordinators and 3 Scientific Managers with diverse backgrounds. Additional colleagues will join the team in 2019 strengthening 3Shape’s growth over the world.

You will interact with a wide range of stakeholders, especially R&D, Product Management, global sales offices and external consultants worldwide. But before anything else, you will be an important member of our regulatory team.

Due to the department´s big network and our way of interaction in 3Shape, you can expect to gain good relations throughout 3Shape, which is a benefit not only for your daily work but also at the legendary Friday Bar.

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 an enthusiastic and international team in an informal workplace
  • A competitive salary and benefits
  • A great location in downtown Copenhagen

About Us

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market-leading scanning and design software solutions for dental labs.

Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,500 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively. www.3shape.com

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 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.

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