Security Risk & Compliance Manager (Risk Management)

We are seeking a proactive and detail-oriented Security Risk & Compliance Manager to lead and implement security risk management and regulatory compliance practices across our medical device software lifecycle.  The ideal candidate will play a key role in identifying, evaluating, and mitigating security risks while ensuring alignment with industry standards and regulatory requirements (e.g., FDA, ISO 13485, HIPAA). Key Responsibilities:  Develop, implement, and maintain the Security Risk Management Plan in alignment with regulatory frameworks and industry best practices.  Identify and assess security threats, vulnerabilities, critical assets, and their potential adverse impacts across all systems and processes.  Conduct risk analysis, evaluation, and control activities to ensure risks are properly documented and managed.  Perform residual risk evaluation and risk-benefit analysis to support informed decision-making for product releases and ongoing operations.  Prepare and deliver security risk management reports, metrics, and dashboards to internal stakeholders and auditors.  Ensure regulatory compliance with applicable cybersecurity standards for medical devices, including pre- and post-market guidance.  Monitor and respond to post-release security threats and coordinate mitigations as needed.  Collaborate closely with Development, QA, and Product Management teams to integrate security best practices across the software development lifecycle. Support internal and external audits, regulatory inspections, and compliance assessments.