Senior Specialist, Global Commercial QA

at  Radiometer

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 Specialist, Global Commercial QA for Radiometer is responsible for ensuring Standard work and QMS for Distributor and Subsidiary Management Globally for Radiometer.
This position is part of the Global Commercial RAQA located in Denmark and across globe and will be fully remote. 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 QA team and report to the Manager, Global Commercial QA responsible for ensuring right level of QMS setup at Distributors and Subsidiaries. If you thrive in a multifunctional, DBS min, fast paced, supporting role and want to work to build a world-class Global Commercial QA organization—read on.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• The preferred candidate holds a Master’s Degree, PhD, or Doctorate in Science, Engineering, Pharmacy, Biology, Biochemistry or the like.
• Minimum of 10+ years of related work experience in Quality/Regulatory Affairs and/or directly supporting functions.
• Detailed knowledge of EU MDD/MDR/IVD/IVDR requirements with experience in vitro diagnostics will be preferred
• Experience in Auditing is an advantage
• Experience with Distributor and Subsidiary Management

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Experience in DBS toolbox will be an advantage
• DM board for relevant processes
• Experience in setting up a QMS from scratch
  At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.
  At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
  At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

• Owns and supports Distributor and Subsidiary Management QMS setup.
• Perform Audits of Subsidiaries and Distributors
• Manage Distributor Agreements (Track and manage Agreements)
• Owns and supports the processes where RMED acts as a distributor.
• Ensure trending of feedback from authorities for the purpose of improving processes