Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
Together with Danaher’s 15+ other operating companies, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day.
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.
HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we’ve been advancing what’s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count.
The Regulatory Affairs Expert is responsible for implementing regulatory processes across global markets and supporting HemoCue teams to ensure patient safety through compliance excellence.
This position reports to the Director RA and is part of the RAQA team located at HemoCue, Ängelholm, Sweden and will be an on-site role. At HemoCue, our purpose is clear: advancing care, test by test, everywhere. Care is the bedrock upon which we stand. It’s manifested in our devices, our people and how we interact with the world.
In this role, you will have the opportunity to:
Lead regulatory strategy and compilation of regulatory submissions
Participate in projects as a regulatory expert, provide input and develop regulatory strategies
Serve as the regulatory point of contact for health authorities and notified bodies
Collaborate cross-functionally with R&D, QA, Clinical, and Marketing teams to support product development and lifecycle management
Monitoring, interpretation and communication of regulations to ensure product compliance
The essential requirements of the job include:
University Degree in Science or Technology
Minimum 3 years of experience of IVDs, medical devices or similar
Knowledge (experience or external training) of applicable regulations and standards affecting the quality management system including but not limited to IVDR/IVDD, ISO 13485, Quality System Regulations for Medical Devices, that are relevant for market authorizations, product registrations, etc
Communication skills (verbal as well as in writing). English language – fluent verbally and in writing, and preferable Scandinavian – fluent verbally and in writing
Drive continuous improvement in regulatory processes and documentation
It would be a plus if you also possess previous experience in:
Collaborate with cross-functional teams to ensure quality and compliance throughout the product and operations processes
Trainer skills to raise awareness of colleagues regarding regulatory requirements
Application
If you want to join a winning team today, please send an application.
Deadline for applying will be August 17th.
For further information, please contact Brian Bratz-Boyd, Senior Director RAQA, +46 734140512
Union contacts: Henrik Pommer, Unionen +46 431 48 12 44 or Katarina Cooper, Akademikerföreningen, +46 431 48 13 02
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.
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.
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.