Description

You will own the security and regulatory compliance lifecycle for medical devices.

Responsibilities

• Ensure compliance with FDA medical device cybersecurity requirements, including Premarket and Post-market Guidance.
• Support 510(k) cybersecurity documentation, including risk assessments, threat modeling, and SBOM generation.
• Perform cybersecurity risk management activities following ISO 14971, identifying hazards and verifying controls.
• Monitor and assess vulnerabilities in third-party software and open-source components (SOUP).
• Support incident response, complaint handling, and CAPA activities related to cybersecurity issues.

Required Skills

• Minimum 8 years of cybersecurity experience, directly involving medical devices.
• Proven expertise in Design History File (DHF) and Risk Management File (RMF) documentation.
• Hands-on experience with VAPT (Hardware & Firmware) and security testing (SAST, DAST, SCA).
• In-depth knowledge of FDA medical device regulations and 510(k) submissions.
• Proficiency in Threat Modeling, SBOM, and SOUP analysis.
• Experience implementing security controls like authentication, encryption, and secure boot.
• Knowledge of ISO 13485 and ISO 14971.
• Bachelor’s degree in Cybersecurity, Computer Science, Software Engineering, Electrical Engineering, or related field.

Key Skills

Education

Bachelor’s degree