The Regulatory Affairs team at 3Shape is expanding, and so are the requirements for surveillance of medical devices once marketed for clinical use in real-life settings. If you are ready to develop and implement the framework that takes our post-market surveillance approach to the next level, then 3Shape offers a unique opportunity to work as Global Post-Market Surveillance Manager in the center of Copenhagen at Kongens Nytorv. This opportunity will help you develop within future disruptive health technologies in collaboration with the wider 3Shape organization.
3Shape´s growth has been steep for the last 15 years. From two guys with a business plan and a master’s thesis prototype to Denmark’s most successful medical device company with more than 1500 employees. No venture capital. No external investments. Just hard work, talent, and grit! A third of all 3Shape staff work in R&D. Innovation is a central part of ‘our DNA’ which fosters a culture of thinking differently. Emphasizing empowerment and taking ownership are key aspects of our culture. We are no longer a start-up, but we take pride in continuing to think like one – together we embrace new ways to exchange ideas and develop unprecedented innovations. All of this helps us to stay engaged with a broad canvas of technologies and applications within dentistry. We simply think and work in an agile way.
Currently, we are 3 Scientific Managers and part of the global RA/QA organization consisting of 9 Regulatory Affairs Specialists/Coordinators, 6 Product Quality Managers/Engineers and 3 Regulatory Affairs Specialists located in Brazil, Korea and Japan.
You will report to the Head of Scientific Affairs and you will be part of our growing global RA/QA organization based in Copenhagen, which currently includes around 20 people. You will interact with a wide range of stakeholders and especially with Development, Customer Support, Product Management and external consultants worldwide.
Your key responsibilities:
Your main responsibility is to develop and implement our new PMS approach based on current and evolving global regulations including EU MDR and MDSAP. In order to do so, you will lead and facilitate the following activities:
As a person, you are a good team player with strong interpersonal skills who thrives in working with multiple stakeholders and partners, both internally and externally. Also, you have the ability to successfully handle multiple tasks while managing tight deadlines and at the same time, you are flexible and know how to reach agreements through dialogue and compromise.
Furthermore, you have: