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 companythat 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.
Tobii Dynavox® is the market leader in assistive technology for communication. Our custom designed communication aids & corresponding support system enable people with disabilities such as cerebral palsy, ALS, autism, spinal cord injury & aphasia to communicate & live their lives to the fullest.
Our offering ranges from eye-controlled communication aids for speech generation to tools for the special education classroom. We empower people with disabilities to do what they once did, or never thought possible, such as expressing themselves in a voice of their own or developing literacy skills. We call this Power to be You, and it explains our belief that every individual has the right to live their life to the fullest, communicate, and live a more independent life. This makes a major impact on the people using our technology and those around them. It also benefits entire communities, healthcare systems & society at large.
With integrated solutions featuring hardware, software, clinically developed language systems, training, and dedicated support, Tobii Dynavox stands out as a truly global, full solution provider in the assistive technology for communication market. There is an enormous unmet need for such products. Globally, around 50 million individuals need communication aids to communicate and interact effectively, while only about 2 million are diagnosed with this need every year. Furthermore, a subset of only about 2%, or 40,000, of those diagnosed are actually served every year due to low awareness, poor implementation support & lack of funding infrastructure — even in some of the most well-developed countries.
We leverage a global distribution network and an extensive funding support system to enable as many as possible to benefit from our communication solutions. Headquartered in Stockholm, Sweden, Tobii Dynavox employs around 500 people and covers a global market with offices in the US, the UK, Germany, China, Norway with reselling partners in 60+ markets.
