Global Regulatory Specialist (MedTech)

TL;DR

Global Regulatory Specialist (MedTech): Ensuring compliance for assistive communication medical devices with an accent on EU MDR and FDA regulatory frameworks. Focus on streamlining regulatory processes, managing technical documentation, and coordinating audit readiness across cross-functional teams.

Location: Must be based in or able to commute to Stockholm, Sweden (Hybrid: 1–3 days onsite per week)

Company

A global leader in assistive communication solutions dedicated to empowering people with disabilities to live richer lives.

What you will do

• Streamline regulatory processes and define roadmaps in collaboration with Product, Development, QA, and Operations teams.
• Coordinate with internal and external auditors to ensure audit readiness.
• Maintain and update technical documentation and declarations of conformity.
• Manage device registrations and listings with the FDA, Authorized Representatives, and importers.
• Support product registrations and market access activities for EU MDR Class I and FDA 510(k)-exempt Class II devices.
• Monitor regulatory changes and communicate implications to relevant stakeholders.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, or Electrical-Electronics.
• Minimum 5 years of experience in medical device regulatory affairs.
• Hands-on experience with EU MDR (Class I) and FDA QSR.
• Proficiency in English (spoken and written).
• Experience with regulatory systems, document control tools, and QMS platforms.
• Ability to explain complex regulatory topics to both technical and non-technical stakeholders.

Nice to have

• Familiarity with embedded systems and IEC 62304.
• Experience with EU MDR (Class II/III).
• Proficiency in German.

Culture & Benefits

• Dynamic, global work environment with a clear, impactful purpose.
• Culture of ongoing learning and professional development.
• Flexible work arrangements supporting work-life balance.
• Collaborative team environment that values individuality and diversity.