Regulatory Affairs Specialist

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 Regulatory Affairs Specialist for Radiometer is responsible for coordination of regulatory activities for our Blood Gas products to help ensure continued compliance worldwide. This position is part of the Global Regulatory Affairs team located primarily in Brønshøj, Denmark and will be on-site. 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 a RA team that supports new product development and ensuring the market access is maintained worldwide with specific focus on EU, US and China. If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work build and want to work to build a world-class regulatory affairs team —read on.

In this role, you will have the opportunity to:

• Plan and execute regulatory activities projects and support design control activities

• Ensure compliance with world-wide regulatory requirements with special focus on EU, US and China

• Generate and maintain GSPRs, STED files and international submissions

• Review impact assessment and perform regulatory assessment of planned changes

• Assess new regulatory requirements with focus on EU and US as well as plan and execute implementation of these

The essential requirements of the job include:

• Master’s degree in science, engineering, pharmacy, biology, biochemistry, biotechnology, medical technology, or similar

• At least 7 years’ work experience as Regulatory Affairs for IVD

• Experience with submissions to regulatory bodies, incl. submissions to notified bodies as well as pre-submissions and 510(k)s submissions to FDA

• Experience with performing change assessments and maintaining STED files.

• Experience with cross-functional work and cross-cultural collaboration

It would be a plus if you also possess previous experience in:

• Detailed knowledge of CLSI guidelines and FDA relevant guidance documents for IVD

• Knowledge about other technical or SME areas such as software, analytical chemistry, usability, stability, UDI, statistics, clinical, post market surveillance

Application:

We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. If you have questions, feel free to contact Director, Regulatory Affairs Hsiao-Qing Chow on hsiaoqing.chow@radiometer.dk. We look forward to seeing your application.

Danaher

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For more information, visit www.danaher.com.

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