Global Regulatory Specialist

Dynavox Group; Stockholms kommun; Hybrid; SEK 900,000 - 1,150,000; Full time

Job summary

A leading assistive technology company is seeking a Global Regulatory Specialist to join their Quality & Regulatory Affairs team in Stockholm. The role requires experience with medical device regulatory affairs, specifically with EU MDR and FDA regulations. Candidates should possess a degree in Regulatory Affairs or related fields and have strong analytical and communication skills. This is a hybrid position requiring occasional onsite presence. If you want to impact lives while advancing your career, apply today!

Qualifications

• 5+ years of experience in medical device regulatory affairs.
• Hands-on experience with EU MDR (Class I) and FDA QSR.
• Proficiency in English, both spoken and written.
• Strong organization, coordination and communication across functions.
• Proficient English in spoken and written communication.

Responsibilities

• Streamline regulatory processes in collaboration with various teams.
• Coordinate with internal and external auditors for readiness.
• Review device classifications and maintain technical documentation.
• Support product registrations and monitor regulatory changes.
• Support registrations with FDA, EU bodies, and distributors; monitor changes.

Skills

Regulatory Affairs

Problem-solving

Detail-oriented

Analytical skills

Communication skills

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or related field

Tools

Quality Management Systems (QMS)

Document control tools

QMS platforms

Regulatory databases

Job description

# **Tobii Dynavox Career Site**See ourGlobal Regulatory Specialist page is loaded## Global Regulatory Specialistlocations: Stockholmtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR100945We’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 . At Tobii Dynavox, you can grow your career within 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.**What's Next**Our Talent Acquisition Team will be operating at reduced capacity during the Christmas and New Year period. We’re still accepting applications, and you’re welcome to submit yours. All submissions will be reviewed from January 7 onwards. We appreciate your patience and wish you happy holidays!**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.