Regulatory Affairs Specialist
Celsus Engineering ABSammanfattning
Join our Quality & Regulatory Affairs team as a Global Regulatory Specialist, where you will ensure compliance of medical devices and mounting systems with global regulations. This hybrid position requires 1-3 days per week onsite in our Stockholm office, with occasional international travel. You will collaborate with various teams to streamline regulatory processes, maintain technical documentation, and support product registrations.Jobbet i korthet
Anställningstyp
visstid
Arbetstid
heltid
Ansök senast: 2026-11-12
Publicerad: 2026-06-29
Beskrivning
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).
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).
Ansök till tjänsten
Regulatory Affairs Specialist
OM FÖRETAGET
Celsus Engineering AB
