GRC Consultant
Chasseur de têtes: Next Ventures
Appareils de technique médicale
Utrecht - Niederlande
Chef de projet / Expert confirmé
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.
Responsabilités
- 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
Principales exigences
- 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
Description du poste
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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