Job Information
Danaher Corporation Director Regulatory Affairs in Angelholm, Sweden
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At HemoCue, one of Danaher’s (https://danaher.com/our-businesses) 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.
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.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
We now seek a dynamic RA leader with a proven track record in managing complex regulatory environments. Your expertise will be instrumental in fostering a culture of continuous improvement and maintaining compliance.
This position is part of the Regulatory Affairs and Quality Assurance team located in Ängelholm, Sweden and will be based on-site at the head-quarter. You will be a part of the leadership team of RAQA at HemoCue and report to the Sr Dir RAQA.
If you thrive in a collaborative, innovative environment and are passionate about enhancing patient care through high quality and strong regulatory practices and want to work to build a world-class regulatory organization do not hesitate to apply for this role.
In this role, you will have the opportunity to:
Ensure compliance with regulatory and internal requirements for the Quality Management System.
Act as Person Responsible for Regulatory Compliance according to delegation from Sr Dir RAQ
Ensure that products comply with necessary requirements before being placed on the market.
Obtain and maintain all necessary authorizations, validations, and certificates for new and existing products.
Ensure that necessary RA resources are represented in all relevant R&D, Operations, Marketing, and Sales activities.
Leading associates within the RA function to drive engagement, continuous improvements to ensure it is a competitive advantage for the business.
The essential requirements of the job include:
M.Sc.- degree in science or equivalent.
At least 5 years of experience in the medical devices industry working with Regulatory processes.
3 years of experience as a leader building people, teams and organizations.
Excellent understanding and in-depth knowledge of regulatory demands for Medical Device/IVDs including ISO13485 and QSR as well as relevant standards and regulations in Canada, Brazil, Japan, Australia and other key markets (FDA, ISO and IVDR).
English – fluent verbally and in writing (Scandinavian is an advantage).
Does this sound interesting? Submit your application today.
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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.