Global Regulatory Specialist

Tobii Dynavox; Stockholms kommun; On-site; SEK 669,600 - 892,800; Full time

Job summary

Tobii Dynavox® is seeking a Global Regulatory Specialist to join their Quality & Regulatory Affairs team. This hybrid role requires you to ensure compliance of medical devices with global regulations, working autonomously and collaboratively in a dynamic environment.

Ideal candidates hold a Bachelor’s degree in a relevant field and possess over 5 years of experience in regulatory affairs. Responsibilities include streamlining processes, coordinating audits, and maintaining technical documentation.

Qualifications

• 5+ years of experience in medical device regulatory affairs with hands-on EU MDR (Class I) and FDA QSR.
• Strong organization and communication skills to engage auditors and stakeholders.
• Proficiency in English, both spoken and written.

Responsibilities

• Streamline regulatory processes and set a roadmap with Product & Development, QA, and Operations.
• Coordinate with internal and external auditors for audit readiness.
• Maintain and update technical documentation and declarations of conformity.

Skills

Regulatory affairs

Problem-solving

Communication

Organization

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences or related field

Tools

Document control tools

QMS platforms

Job description

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.

Responsibilities

• Streamline regulatory processes and set a roadmap in collaboration with 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.
• 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.

Qualifications

• 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.
• 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 communicate 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

• Familiarity with embedded systems and experience with IEC 62304.
• Experience with EU MDR (Class II/III).
• Additional languages such as German.

Equal Opportunity Employer

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