Regulatory Affairs Specialists

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

Then 3Shape offers a unique opportunity to work as our new Regulatory Affairs Specialist in the center of Copenhagen at Kongens Nytorv. This opportunity will help you develop within future disruptive health technologies together with the entire organization and with exposure to senior management.

About the department
As a Regulatory Affairs Specialist, you will join our Global Regulatory Affairs team based in Copenhagen. We are currently a team of nine Regulatory Affairs Specialists/Coordinators and one Scientific Manager with diverse backgrounds. Six additional colleagues are expected to join the team in 2018. You will interact with a wide range of stakeholders and especially with R&D, Product Management, Global Sales offices, and external consultants worldwide.

The Job
The main purpose of this position is to obtain and maintain regulatory approvals for our highly innovative dental scanners and/or software products to ensure their registration globally. You will be a member of the product development team and contribute with your regulatory expertise, e.g., advice in the creation of the technical file and develop and maintain the products´ regulatory strategy. 

As 3Shape often introduce new products, you can have the opportunity of being involved from the very first meetings about a new product, getting a deep insight of the processes associated with the product launch of a medical device.  In addition, there are also several internal RA projects you will be involved in, e.g., the new Medical Device Regulation, or process improvements. You will have the opportunity 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, engineering, or similar
• Minimum 3 years of regulatory experience within the medical device industry. Knowing the regulatory landscape for active and/or software-based medical devices is considered an advantage
• Having a diverse work history, e.g., as a developer of technical or software devices is considered an advantage
• Having strong interpersonal skills and a positive attitude towards colleagues requiring regulatory guidance or who challenge a regulatory approach
• Proficient in English
• Experience with working both independently and in teams

We offer

• A professional challenge in a highly dynamic and 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
• Nice offices in downtown Copenhagen

Application
Apply for this position already today and upload your transcripts together with your CV and cover letter as we interview continuously. Please apply via the link “Ansøg”. We look forward to hearing from you!

Read more about working at 3Shape at www.3shape.com/Corporate/Careers

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