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.

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).