Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
Learn about the Danaher Business System which makes everything possible.
The Regulatory Affairs Analyst I for Beckman Coulter Diagnostics is responsible for management of products registration, maintenance/update of IVDR documentation, management of CAPA process and support of the team in all other QRA activities.
This position is part of the Quality and Regulatory Affairs (QRA) department located in Prague and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Quality and Regulatory Affairs team and report to the Quality and Regulatory Affairs Supervisor responsible for several QRA processes . If you thrive in a multifunctional, fast paced role and want to work to build a world-class organization focused on quality and regulatory — read on.
In this role, you will have the opportunity to:
+ Ensure activities related to registration of our products
+ Maintain and update IVDR documentation
+ Manage CAPA process
+ Support supplier quality activities
+ Work in a small team providing all QRA activities
The essential requirements of the job include:
+ B.Sc., M.Sc., or PhD in chemistry, biochemistry, biology or other relevant technical field
+ Fluent Czech, upper intermediate spoken and written English
+ Flexibility in learning new issues in the areas of quality assurance and regulatory affairs
+ Sense of teamwork
It would be a plus if you also possess previous experience in:
+ Quality, Regulatory or other relevant functional role within a regulated industry
+ Quality assurance systems based on EN ISO 13485
+ production of in-vitro diagnostic devices
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 .
