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 Radiometer products for Turkey to help ensure continued compliance in these markets and growing the Radiometer market share.

This position is part of the Global Commercial Regulatory Affairs department. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Global Commercial Regulatory Affairs team, responsible for ensuring the market access is maintained and that we grow our business by Regulatory registrations in new markets. 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, your tasks:

As part of licensing and registration procedures for our products (medical devices and IVD) your main tasks include:

• Preparation and timely submission of registration documents for Turkey
• Support for regulatory approvals for Turkey and countries in this commercial region. Review of the content of regulatory documentation related to relevant Regulatory Guidelines
• Tracking, evaluation and, if necessary, implementation of country-specific regulatory requirements in working closely with Regulatory team in Denmark (Radiometer Denmark on new, upcoming or changes in regulations/requirements)
• Ensure an establishment license is updated and maintained
• Ensuring the compliance of labelling (labels, IFUs, inserts, Manuals) for our products according to RA requirements
• Follow-up on the registration dossiers submitted to the Authorities.
• Assist with audit activities onsite

The essential requirements of the job include:

• You have completed a scientific university degree and have min 5 years of professional experience in regulatory.
• Good command of English
• You have strong technical knowledge of medical products and terminology.
• You have strong analytical and organizational skills with the ability to multi-task and prioritize competing demands.
• You are a proactive team player and handle your tasks with a high degree of independence, carefully and on schedule.
• You have ability to identify issues and take appropriate actions according to corporate guides and policies.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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