Global Regulatory Specialist
3 days ago
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.
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