GRC Consultant – ISO/IEC 27001 Controls for a regulated medical device company. Responsible for supporting the design, implementation, and operation of an ISO/IEC 27001–aligned ISMS, integrating information security governance, risk management, and compliance with medical device regulatory and quality requirements.
Contract / Permanent
Immediate
Day Rate + Expenses / Fixed Package (dependent on engagement type and experience)
Hybrid / On-site (Utrecht)
Language: English (mandatory)
The client is seeking an experienced GRC Consultant with strong ISO/IEC 27001 controls expertise and prior experience in regulated environments, ideally medical devices, healthcare, or life sciences. The consultant will work closely with Quality, Regulatory Affairs, IT, and R&D teams to ensure information security controls are aligned with both ISO standards and medical device regulations.
Implement, review, and maintain ISO/IEC 27001 and ISO 27002 controls
Develop and maintain ISMS documentation, including policies, procedures, risk assessments, and Statement of Applicability (SoA)
Conduct information security risk assessments aligned with ISO 27005 and integrated with ISO 14971 product risk management
Support internal audits, certification audits, and regulatory inspections
Align security controls with ISO 13485, FDA QSR (21 CFR 820), and relevant IEC standards (e.g., IEC 62304, IEC 81001-5-1)
Support supplier and third-party security risk assessments
Track remediation actions, KPIs, and continuous improvement activities
Strong hands-on experience with ISO/IEC 27001 and ISO 27002 controls
Proven GRC consulting experience in regulated industries
Experience working within or alongside Quality Management Systems (ISO 13485 / FDA QSR)
Solid understanding of information security risk management frameworks
Experience supporting audits and compliance assessments
Excellent documentation and stakeholder communication skills
ISO/IEC 27001 Lead Implementer or Lead Auditor certification
Medical device or healthcare cybersecurity experience
Familiarity with IEC 62304, IEC 81001-5-1, HIPAA, and/or GDPR
Experience working with cloud environments and third-party risk management
Background collaborating with R&D or product security teams
jude.russell@next-ventures.com