About the positionAs a Global Regulatory Specialist, you will join our client's global Quality & Regulatory Affairs function and play a key role in ensuring that medical devices and mounting systems comply with regulatory requirements across international markets. You will become part of a central regulatory team based in Stockholm, supporting a global organization that operates in more than 80 countries and holds a market-leading position within assistive communication solutions.The role combines operational responsibilities with strategic influence. While maintaining existing regulatory processes, you will also support the organization by interpreting regulatory changes, providing expert guidance, and ensuring continued market access for the company's products.Key responsibilities:Maintain and improve technical documentation, including Annex II & III documentation and EU Declarations of Conformity.Coordinate product registrations and device listings with regulatory authorities, including the FDA, Authorized Representatives, and distributors.Support regulatory compliance activities related to EU MDR Class I products and FDA 510(k)-exempt Class II devices.Review device classifications and assess regulatory implications across global markets.Coordinate internal and external audits and support audit readiness activities.Monitor changes in global regulatory requirements and communicate their impact throughout the organization.Collaborate closely with Product Development, Quality, Operations, and other cross-functional teams to ensure regulatory compliance throughout the product lifecycle.This is a highly collaborative global role with frequent interaction with colleagues across Europe, North America, Asia, and Australia. While most collaboration takes place virtual…Regulatorisk handläggare/Regulatory affairs specialistFarmakologer och biomedicinare
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