Global Regulatory Specialist

Job description

Why Join Us? We’re on a mission to empower people with disabilities to do what they once did or never thought possible. As the world-leader in assistive communication solutions, we empower our customers to express themselves, connect with the world, and live richer lives . At Tobii Dynavox, you can grow your career within a dynamic, global company that has a clear, impactful purpose - with the flexibility to also do what truly matters to you outside of work. What’s more, you’ll be part of a work culture where collaboration is the norm and individuality is welcomed. As a member of our team, you’ll have the power to grow ideas in an unconventional environment. At the same time, you’ll work in a culture of ongoing learning and development, allowing you to constantly expand your area of expertise. 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. What We’re Looking For We 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 regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance Strong organization, coordination and communication skills to engage auditors and communicating with stakeholders across functions and levels. Ability to break down complex regulatory topics clearly for both technical and non-technical stakeholders. Proficiency in both spoken and written communication in English. Ideal candidates will bring: Familiarity with embedded systems and experience with IEC 62304. Experience with EU MDR (Class II/III). Additional languages such as German. Apply today! We believe in empowering individuals - including our own employees - to reach their full potential. So, if you want to change lives while growing your own career, we’d love to hear from you. Where we stand: We believe diversity not only enriches our workplace culture, but also gives us a strategic advantage. Working with people from a variety of backgrounds and perspectives helps us all become better communicators, better problem solvers, and better human beings. Our differences make us stronger. Tobii Dynavox values equality of opportunity, human dignity, and racial/ethnic and cultural diversity. Tobii Dynavox does not discriminate against individuals on the basis of race, color, sex, sexual orientation, gender identity, religion, disability, age, veteran status, ancestry, or national or ethnic origin. Equal Opportunity Employer/AA Women/Minorities/Veterans/Disabled