ISMS & Compliance Architect – ISO 27001 (MedTech)

Seres Information Technologie Limited; Göteborgs kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Seres Information Technologie Limited in Sweden/Gothenburg is seeking an IT Security and Compliance Framework Specialist to maintain and improve the company’s ISMS and IT compliance framework, monitor KPIs, coordinate audits and risk assessments, manage CAPAs and review policies to stay aligned with ISO 27001, GDPR, NIS2 and FDA 21 CFR Part 11.

The ideal candidate has at least three years of ISMS/QMS experience, strong ISO 27001 expertise, and preferably CISM or CISA certification with MedTech

Qualifications

• Minimum 3 years of ISMS/QMS/EHS management system experience.
• Experience in maintaining Information security management system as per ISO/IEC 27001 is required.
• Preferred certified security professional within one or more areas such as CISM, and CISA.
• Preferred experience from work within Pharma or Medtech industry.
• Good understanding of Data Privacy (e.g. GDPR) regulations is desired.
• Good understanding of medical device regulations (e.g. FDA 21 CFR Part 11, ISO 62304, ISO 81001-5-1) is desired.
• Awareness from agile development and DevSecOps methods including understanding of end-to-end Software Delivery Lifecycle processes.

Responsibilities

• Maintain and improve the company's ISMS and IT compliance framework.
• Monitor KPIs.
• Coordinate audits and risk assessments.
• Manage CAPAs.
• Review policies and ensure alignment with ISO 27001, GDPR, NIS2, and FDA 21 CFR Part 11.

Skills

ISMS/QMS management

ISO 27001 expertise

GDPR knowledge

NIS2 awareness

FDA 21 CFR Part 11 familiarity

CISM

CISA

Pharma/Medtech experience

Agile/DevSecOps awareness

Job description

Seres Information Technologie Limited in Sweden/Gothenburg is seeking an IT Security and Compliance Framework Specialist to maintain and improve the company’s ISMS and IT compliance framework, monitor KPIs, coordinate audits and risk assessments, manage CAPAs and review policies to stay aligned with ISO 27001, GDPR, NIS2 and FDA 21 CFR Part 11.

The ideal candidate has at least three years of ISMS/QMS experience, strong ISO 27001 expertise, and preferably CISM or CISA certification with MedTech