Senior Regulatory Affairs Scientist

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. 

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Senior Regulatory Scientist for Radiometer is responsible for regulatory and scientific guidance through all phases of a project and product life cycle to support continued business growth and compliance worldwide.

This position is part of the Global Regulatory Affairs team located primarily in New Brighton, MN and will be REMOTE. Some international travel to the Danish office in Brønshøj, Denmark is to be expected. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Regulatory Affairs and Quality Affairs and report to the Director, Regulatory Affairs responsible for an RA team that supports new product development and ensures market access is maintained worldwide with specific focus on EU, US and China. If you thrive in a fast-paced environment, are used to playing a critical supporting and coordinating role and want to work to build a world-class regulatory affairs team —read on.

In this role, you will have the opportunity to:

• Provide regulatory guidance through all phases of a project, research and development, pre-clinical and clinical testing, and final data analysis and write specific sections of regulatory submissions
• Provide regulatory and scientific guidance and mentoring of SMEs in different functional areas
• Advise on regulatory strategy and submissions based on the latest regulatory bodies thinking and guidelines (e.g. FDA, EU, ICH, etc.).
• Assist the project teams in developing and interpreting valid scientific evidence to demonstrate that the device meets the requirements and expectations of regulatory bodies on safety, efficacy, quality and performance.

The essential requirements of the job include:

• Bachelor’s degree or master's in a scientific field (, …