Regulatory Affairs Specialist

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.

Requirements

• 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).

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Company Intel

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