Product Security Analyst

Job Summary

A company is looking for a Product Security Regulatory & Process Analyst to strengthen and sustain product security governance for regulated medical devices.

Key Responsibilities

• Serve as a subject matter expert for product security regulatory compliance with FDA cybersecurity guidance and global medical device regulations
• Support the creation and continuous improvement of product security policies, SOPs, and work instructions
• Translate product security requirements into actionable requirements and ensure traceability within the requirements tool

Required Qualifications

• Experience with medical devices and cybersecurity in a regulated environment
• Understanding of FDA regulations related to medical device products
• Experience working with regulated products and development processes
• Ability to collaborate across engineering, quality, regulatory, and security teams
• Interest in medical device cybersecurity and willingness to grow expertise in this area