Director Regulatory Affairs

At HemoCue, our vision is to do things easier, to do things better, and to do them right.

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).

Applications will be read and reviewed throughout the application period; this means the position might be filled prior to the last date of advertising November 30th, 2024.

Welcome in with your application!