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!