Are you ready to continue your regulatory career within digital health care working with 3D medical scanners in a global setting? 3Shape offers a unique opportunity to work as a Regulatory Affairs Specialist where you will work with state-of-the-art dental technologies.
- A professional challenge in a highly dynamic globally oriented business environment
- Informal atmosphere, among best in class colleagues with a strong emphasis on supporting creativity and fostering well-being of the employees
- A large degree of independence and freedom to plan and streamline your own tasks
- Competitive employment terms and benefits
- An attractive work environment in a brand-new production facility with canteen and observation deck.
- Stable employment conditions (contract of employment)
- Personal growth and development through continuous learning
- Fruit, vegetables, snacks to keep you fueled
- Seasonal parties to keep you connected with colleagues (and hopefully dancing)
We seek a Regulatory Affairs Specialist to help obtain and maintain regulatory approvals for our highly innovative intra oral dental scanners.
You will work with national registration of electronic medical devices around the globe. During registration work you will be in direct contact with consultants and relevant notified and regulatory bodies globally. You will further work on labeling of our products and in ensuring that our label requirements are implemented in Production both in our Polish and Chinese factory. Finally, you will interact with development on requirements for new products and get involved in the MDR transition work.
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.
The ideal candidate is a hands-on, implementer who enjoys working in a cross functional team, and further has most of the following qualifications:
- A Master’s degree within engineering, natural sciences or similar
- Ability to find the fastest path to market access for our products
- Experience with medical device regulations; MDD/MDR, 21 CFR 820, ISO 13485 and MDSAP
- Regulatory experience within the electronic medical device industry, e.g. preparation of a 510(k)
- Experience with development or production of medical devices
- Knowledge of the regulatory landscape in e.g. China, Japan, Brazil and Korea
