Cyber Security Consultant – Product Security & Regulatory Compliance (m/f/d)

A medical technology company is looking for an experienced Cyber Security Consultant to act as an independent advisor at the interface of software architecture, DevOps and regulatory affairs. The project aims to develop and secure innovative digital health products (Software as a Medical Device / Connected Devices). The position involves purely technical consulting, technical assessments and the delivery of validated security artefacts, without operational management decisions. The focus is on translating regulatory requirements (FDA, MDR, EU CRA, NIS2) into technical solutions and objectively assessing security risks.

• Holistic Threat Modeling: Conduct STRIDE-based analyses for APIs, cloud-native services, AI components and CI/CD pipelines, and maintain formal threat model reports.
• Security Architecture & Design: Create technical data flow diagrams (DFD) and security architecture review reports to document security decisions in cloud and container environments.
• DevSecOps & Supply Chain Security: Advise on hardening CI/CD pipelines, implementing "security-by-default" and managing SBOM artefacts (third-party risk).
• Penetration Testing Support: Define the scope for pen tests and fuzzing, and technically validate the results and CVSS scores.
• Vulnerability Management: Assess vulnerabilities (vulnerability impact assessments) and develop remediation plans.
• Audit Preparation: Compile technical evidence and documentation for regulatory submissions (FDA, MDR, MDS2).

• Degree in Computer Science, Cyber Security or Engineering.
• 5–8+ years of project experience in product security, application security or security architecture.
• Excellent knowledge of threat modeling (STRIDE, PASTA), risk assessments (CVSS) and secure SDLC.
• Deep expertise in cloud security (Azure/AWS), containerization (Kubernetes/Docker), API security and CI/CD toolchains.
• Experience with AI/ML security is a plus.
• Proven experience with medical technology standards (FDA Cybersecurity Guidelines, EU MDR, ISO 14971, IEC 62304) or comparable critical standards (ISO 21434, IEC 62443).
• Ability to drive technical topics independently as an advisor, with a structured, "audit-ready" documentation style.
• Fluent English (C1/C2) is mandatory (project and documentation language).
• German fluent (B2/C1) is desirable.
• Relevant certifications such as CISSP, CCSP, CSSLP, CISM or OSCP are highly desired.