Regulatory Affairs Specialist

Celsus Engineering AB; Sweden; Hybrid; SEK 45,000 - 70,000; Full time

Job summary

Celsus Engineering AB, based in Sweden, is seeking a Global Regulatory Specialist to join its Quality & Regulatory Affairs team. The successful candidate will help ensure compliance with global regulatory standards for medical devices, working in a hybrid role with some onsite presence in Stockholm.

The ideal candidate has a bachelor's degree in a relevant field and at least 5 years of experience in medical device regulatory affairs. Strong skills in problem-solving, communication, and organization are essential.

Qualifications

• 5+ years of experience in medical device regulatory affairs, with EU MDR and FDA QSR experience.
• Hands-on experience with regulatory compliance, technical documentation, and audits.
• Strong proficiency in spoken and written English.

Responsibilities

• Streamline regulatory processes and set a roadmap in collaboration with teams.
• Coordinate internal and external audits to support audit readiness.
• Review device classifications and update technical documents for compliance.

Skills

Detail-oriented

Problem-solving

Communication skills

Analytical skills

Organization skills

Education

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

Tools

Regulatory systems

Document control tools

QMS platforms

Job description

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).