Regulatory Specialist
Boule Diagnostics AB is a global diagnostics company that develops, manufactures and markets instruments and consumable products for blood diagnostics. The company serves hospitals, clinics, laboratories and companies within blood diagnostics, in both human and veterinary hematology. The company operates via subsidiaries in Sweden, the USA, Mexico and Russia. The company products are sold globally primarily through distributors, supported by Boule’s own local sales and support personnel. The Boule shares are listed on Nasdaq Stockholm since 2011.
Join our Quality and Regulatory Affairs team as a Regulatory Affairs Specialist and play a critical role in shaping our products for international markets.
This position is perfect for an independent, driven professional with a deep knowledge of MDR/IVDR and quality assurance, looking to impact both ongoing and new development projects.
You’ll work closely with R&D and marketing teams and report to the Head of Quality and Regulatory Affairs, Sweden and RoW. Our office is located in Spånga, Stockholm, with hybrid work arrangements available.
Why Join Us?
Innovate at Scale: Contribute to the global advancement of blood diagnostics technology.
Influence and Impact: Be an integral part of our regulatory landscape, guiding compliance and safety measures.
Collaborative Environment: Engage with cross-functional teams across R&D, marketing, and global compliance.
Key Responsibilities:
-Lead vigilance activities, including authority liaison, recalls, and advisory notices.
-Provide regulatory expertise in new product development, assessing region-specific compliance requirements.
-Interface with Notified Bodies and authorities on substantial system changes and new product designs.
-Review design dossiers, technical files, and labeling to secure regulatory approval.
-Stay informed on regulatory updates to maintain proactive compliance.
Who You Are
-You have experience in performing submissions in both EU and USA.
-Solid knowledge of applicable standards for the medical device sector, specifically IVD.
-Several years working within regulatory affairs.
-Good understanding of registration process on a global level.
-Fluent in English and Swedish
On top of being part of a great QARA team in an important and fun role you will be part of developing our regulatory strategy and take our ways of working to the next level.
Selection takes place continuously so send in your application right away!
If you have any questions related to the role or the life at Boule, kindly connect with responsible department manager Niklas Lundqvist at [email protected] or HR at [email protected].