MedTech IT Security & Compliance Specialist (Hybrid – Gothenburg)

RED Global; Göteborgs kommun; Hybrid; SEK 600,000 - 900,000; Full time

Job summary

RED Global is seeking an IT Security and Compliance Framework Specialist to join a 6-month contract for a global MedTech leader. Hybrid work in Gothenburg (3–4 days onsite, some flexibility for fewer onsite days). ASAP start. You will manage ISMS/QMS, implement GDPR/NIS2/FDA 21 CFR Part 11 controls, and lead audits and policy development.

The role emphasizes risk assessments, CAPA closure, and alignment with Agile/DevSecOps in a regulated environment. Experience in MedTech or Pharma is preferred.

Qualifications

• 3+ years in management systems (ISMS / QMS) with focus on IT compliance frameworks.
• Strong knowledge of GDPR, NIS2, and FDA 21 CFR Part 11.
• Expertise in maintaining ISMS per ISO/IEC 27001.
• Experience with risk assessments, internal/external audits, CAPAs, and policy development.
• MedTech or Pharma sector experience preferred.
• CISM or CISA certifications are advantageous.
• Understanding of Agile, DevSecOps, and SDLC processes.

Responsibilities

• Oversee management systems ISMS/QMS with IT compliance focus.
• Maintain ISO/IEC 27001 ISMS.
• Conduct risk assessments and audits, manage CAPAs.
• Develop policies and ensure regulatory compliance.
• Collaborate in MedTech/Pharma environments.

Skills

IT compliance frameworks

Regulatory knowledge

Information Security Management

Audits & CAPA management

Job description

RED Global is seeking an IT Security and Compliance Framework Specialist to join a 6-month contract for a global MedTech leader. Hybrid work in Gothenburg (3–4 days onsite, some flexibility for fewer onsite days). ASAP start. You will manage ISMS/QMS, implement GDPR/NIS2/FDA 21 CFR Part 11 controls, and lead audits and policy development.

The role emphasizes risk assessments, CAPA closure, and alignment with Agile/DevSecOps in a regulated environment. Experience in MedTech or Pharma is preferred.