GRC Consultant

Headhunter: Next Ventures

Medical Devices

Utrecht - Niederlande

Senior Specialist / Project Manager

Experteer Overview

In this role you will design, implement, and operate an ISO/IEC 27001-aligned ISMS for a regulated medical device environment. You will partner with Quality, Regulatory Affairs, IT, and R&D to align security controls with ISO standards and medical device regulations. You’ll conduct risk assessments, support audits and regulatory inspections, and drive continuous improvement across governance, risk, and compliance. This is a hands-on consultancy that helps bridge security with product development and regulatory requirements, delivering measurable risk reduction.

Responsibilites

Implement, review, and maintain ISO/IEC 27001 and ISO 27002 controls
Develop and maintain ISMS documentation (policies, procedures, risk assessments, SoA)
Conduct information security risk assessments aligned with ISO 27005 and ISO 14971
Support internal audits, certification audits, and regulatory inspections
Align security controls with ISO 13485, FDA QSR (21 CFR 820), and IEC standards (IEC 62304, IEC 81001-5-1)
Support supplier and third-party security risk assessments
Track remediation actions, KPIs, and continuous improvement activities
Collaborate with Quality, Regulatory Affairs, IT, and R&D to integrate security with regulatory requirements

Key requirements

ISO/IEC 27001 Lead Implementer or Lead Auditor certification
Strong hands-on experience with ISO/IEC 27001 and ISO 27002
GRC consulting experience in regulated industries
Experience with ISO 13485 / FDA QSR (21 CFR 820)
Solid understanding of information security risk management frameworks
Experience supporting audits and compliance assessments
Medical device or healthcare cybersecurity experience
Familiarity with IEC 62304, IEC 81001-5-1, HIPAA, and/or GDPR
Experience with cloud environments and third-party risk management
Experience collaborating with R&D or product security teams

excellent documentation stakeholder communication cross-functional collaboration ISO/IEC 27001 ISO 27002 ISO 27005

Description

In this role you will design, implement, and operate an ISO/IEC 27001-aligned ISMS for a regulated medical device environment. You will part…

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