Regulatory Affairs Manager

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 Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world. In addition, the Regulatory Affairs Manager is tasked with improving the efficiency and effectiveness of the regulatory affairs department's processes, which will help Radiometer navigate complex regulatory environments more easily.

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 International Registration team and report to the Global Director for RA, who are responsible for overseeing and ensuring the market access is maintained worldwide. If you thrive in a fast-paced environment, are used to playing a critical supporting 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 on a global scale - read on.

In this role, you will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders
• Secure continued support to the RA Regulatory Intelligence process, including stakeholder management with local RA
• Manage and resource RA support to commercial release
• Plan and execute projects for new regulatory requirements

The essential requirements of the job include:

• Master 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 as a people manager
• Experience with cross-functional work
• Core Team member for complex development or maintenance project, e.g., spanning across a portfolio, rather than a single product
• Experience with cross-cultural collaboration

Radiometer

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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