Global Regulatory Specialist

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.