About the RoleAs a Global Regulatory Specialist, you will join our Quality & Regulatory Affairs team to help ensure our medical devices and mounting systems meet global regulatory requirements. Please note: This is a hybrid role with 1–3 days per week onsite at our Stockholm office in Östermalm, especially during onboarding. Occasional international travel (10–20%) may be required and will be communicated in advance. In this role you will:Streamline regulatory processes and set a roadmap in collaboration Product & Development, QA, and Operations teams.Coordinate with internal and external auditors to support audit readiness.Review device classifications and regulatory challenges across markets.Maintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation.Coordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers/Distributors.Support product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II).Monitor regulatory changes and communicate implications to relevant teams. What We’re Looking ForWe are looking for a structured and collaborative regulatory professional who enjoys solving problems with a logical approach, works autonomously while contributing to strategic initiatives, and thrives in a dynamic, cross-functional environment. We’re looking for a detail-oriented and analytical professional with:A bachelor’s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field.At least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR.Experience with regu…

Regulatory Affairs Specialist