Global Regulatory Specialist

Why Join Us

Were 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. Whats more youll be part of a work culture where collaboration is the norm and individuality is welcomed.

As a member of our team youll have the power to grow ideas in an unconventional environment. At the same time youll 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 13 days per week onsite at our Stockholm office in Östermalm especially during onboarding. Occasional international travel (1020%) 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 Were 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.

Were looking for a detail-oriented and analytical professional with:

• A bachelors 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 wed love to hear from you.