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 RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

This position is part of the Global Regulatory Affairs department located in Brønshøj, Denmark and will be Hybrid position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Blood Gas Regulatory Affairs team and report to the Hsiao-Qing Chow, Director, RA responsible for the team that supports new product development RA and ensuring the market access is maintained in the major markets (EU, China & US).

If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work to build a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

The essential requirements of the job include:

• Master’s degree, e.g., engineering, biotechnology, pharmaceutical sciences, medical technology, or similar science field
• At least 3 years’ experience in Regulatory Affairs within In vitro Diagnostic Devices or medical devices
• Experience writing regulatory submissions for EU, US, or China
• Experience with cross-functional work
• Experience with cross-cultural collaboration

Hybrid
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Application
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Placering
Bronshoj, Denmark, state: , cityCountry: Bronshoj, Denmark