Hemo Cue 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. Hemo Cue offers point-of-care testing for hemoglobin, glucose and Hb A1c as well as total and differential white blood cell count.

Hemo Cue is proud to be part of Danaher.

Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow’s science and technology to improve human health.
Are you an expert in regulatory affairs and quality assurance, driven by a passion to make a tangible difference in patients' lives? Hemo Cue is looking for a leader with a global mindset to take on the key role as Senior Director for Regulatory Affairs and Quality Assurance.

At Hemo Cue, we are committed to fulfill customer needs by innovative products to advance care. You will be part of our Senior Leadership Team, based in Ängelholm, Sweden.

Your Impact:

• Leadership & Strategy: Develop, implement and maintain our Quality Management System, ensuring it meets and exceeds all relevant regulations.
• Global Collaboration: You will also be part of the Global RA/QA Leadership Team at Radiometer, reporting into the VP of RA/QA, with a dotted line to the President of Hemo Cue.
• Compliance Excellence: Navigate the dynamic landscape of international regulations, ensuring Hemo Cue remains at the forefront of compliance and quality standards.

We seek a dynamic RA/QA 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. If you thrive in a collaborative, innovative environment and are passionate about enhancing patient care through high quality and strong regulatory practices, 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.
• Serve as the Person Responsible for Regulatory Compliance and Management Representative for Quality for Hemo Cue.
• Decide upon field action and reportable events to ensure compliance with regulatory requirements.
• 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/QA resources are represented in all relevant R&D, Operations, Marketing, and Sales activities.
• Leading leaders and associates within the RA/QA 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.
• 7 years of experience in the medical devices industry with 5 years working with Quality and Regulatory process.
• 5 years of experience as a leader building people, teams and organizations.
• Excellent understanding and in-depth knowledge of regulatory demands 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).

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.