Senior Specialist - Product Security

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Support execution of product cybersecurity post-market surveillance activities across the product portfolio by monitoring security events, vulnerabilities, and emerging threats impacting products and connected systems.
• Monitor, track, analyze, and document cybersecurity complaints, incidents, vulnerabilities, threat intelligence findings, and post-market security observations in accordance with established processes and regulatory requirements.
• Assist in maintaining cybersecurity risk registers, issue trackers, remediation status reports, metrics dashboards, and portfolio-level security records to support ongoing risk management activities.
• Support coordinated vulnerability disclosure (CVD) and product security incident response processes through vulnerability triage, stakeholder coordination, remediation tracking, escalation support, and documentation management.
• Contribute to vulnerability assessments, penetration testing activities, phishing simulations, threat intelligence reviews, and security monitoring initiatives to identify and mitigate product and application security risks.
• Support the preparation and maintenance of post-market surveillance (PMS) evidence, cybersecurity assessment reports, audit documentation, compliance records, and risk analysis artifacts.
• Maintain and enhance standardized cybersecurity procedures, templates, SOPs, playbooks, and operational guidelines to ensure consistency across product security and surveillance activities.
• Coordinate recurring cybersecurity operational activities with cross-functional teams including R&D, Quality, Regulatory, Engineering, Privacy, and IT stakeholders to support timely risk assessment and remediation efforts.
• Support portfolio-wide documentation readiness for internal audits, external assessments, regulatory submissions, and compliance reviews related to product cybersecurity.
• Assist in refining security monitoring capabilities, incident detection processes, reporting mechanisms, and automation opportunities to improve operational efficiency and threat response effectiveness.
• Maintain awareness of evolving cybersecurity threats, software and hardware vulnerabilities, medical device cybersecurity regulations, and industry best practices relevant to product security and post-market monitoring.
• Support awareness and communication initiatives by contributing to cybersecurity training, knowledge-sharing activities, and stakeholder guidance related to product security risks and responsibilities.
• Prepare periodic reports and metrics on cybersecurity incidents, vulnerabilities, remediation status, and post-market surveillance trends, including recommendations for continuous improvement and risk mitigation.
• Participate in operational review meetings, cross-functional governance discussions, and status tracking activities to ensure effective coordination, transparency, and continuity of cybersecurity operations and post-market surveillance activities.