Global Regulatory Specialist

About the role

As 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.