Head of Regulatory Affairs, Software

3Shape is looking for a Head of Regulatory Affairs for our software medical devices
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At 3Shape we are extremely proud of our market-leading and award-winning 3D scanners and medical device software solutions. And with our newly released corporate strategy, we focus even more on the development of the right solutions for our customers. And in order to ensure that such solutions become available globally at a fast pace, 3Shape is looking for a Head of Regulatory Affairs for our software medical devices. This opportunity will facilitate your leadership development within software-based health technologies.

The Software Regulatory Affairs Team

The team consists of 5 Regulatory Affairs Specialists with diverse backgrounds who are responsible for all regulatory activities linked to product development and market expansion activities. For Korea, China and Japan this is done in close collaboration with our country-based Regulatory Affairs Specialists located in Korea, China and Japan. Additional colleagues may join the team in 2021.

The job 

 You will be leading and developing your team of Regulatory Affairs Specialists in order to execute our global regulatory strategies and provide regulatory input and advice to our software development teams. Reporting to the Director of Regulatory Affairs, you will interact with a wide range of stakeholders, especially R&D, Product Management, global sales offices, external consultants and distributors. You will also take part in cross-organizational improvement projects as well as in external audits. 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 organizational awareness and collaboration skills. In addition, you are proactive by nature and take a highly structured approach to your work while being flexible and know how to reach agreements through dialogue and compromise. At the same time, you are motivated by developing people and contributing with new ideas optimizing the regulatory workflow.

Furthermore, you have:

  • Minimum 5 years of experience from the medical device industry within regulatory affairs - preferably with stand-alone software devices.
  • Very good knowledge of global legislation and standards (e.g. ISO, 13485, MDSAP, FDA CFR 820, ISO 62304, ISO 14971, ISO 62366) applicable to the medical device industry.
  • Leadership experience (people management or project management). Alternatively, you have an interest in leading and developing people.
  • A good understanding of software structures and interfaces as well as cybersecurity requirements.
  • Have experience with collaboration and communication with management teams on planning and executing regulatory strategies.
  • An interest for working in a multi-cultural environment with people who have various educational or work backgrounds.
  • Solid communication skills. In addition, you speak and write English fluently.

We offer

  • An opportunity to change dentistry together with dental professionals across the world by ensuring innovative solutions that provide superior patient care are made available globally. 
  • A professional challenge in a highly dynamic globally oriented business environment.
  • The chance to become part of an enthusiastic and international team with great and very skilled colleagues in an informal atmosphere.
  • Healthcare insurance package
  • A great location in downtown Copenhagen, Kongens Nytorv.

Get in touch now!

If you think you’re up for the challenge, we’d be happy to receive your application including motivational cover letter and CV as soon as possible as we will interview continuously. If you have any questions, please contact Antje Marquardsen at +45 2494 1449.

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.

 

We encourage all relevant applicants to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status. All qualified applicants will be given equal opportunity and the selection is based on job-related factors.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,600+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook.

Or, know someone who would be a perfect fit? Let them know!

DK - Copenhagen

Holmens Kanal 7
1060 København Directions View page

Our biggest assets are our people and culture 💗

Life at 3Shape is great! We bring passion and talent to work every day to innovate for superior patient care. 3Shape is built on a culture of thinking differently and being innovative when solving challenges. We embrace new ways to exchange ideas with colleagues across departments and think and work in an agile way. Experience the everyday #lifeat3Shape across the globe on Facebook. 

Already working at 3Shape?

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