Technical Product Security Compliance Manager

3 days ago

Lincolnshire Illinois, United States Sysmex Full time
About the Role

We are seeking a highly skilled and experienced Technical Product Security Compliance Manager to join our team at Sysmex. As a key member of our organization, you will be responsible for the development, maintenance, and operations of our cybersecurity program for medical device software products.

Key Responsibilities
  • Provide consultation services to leadership on cybersecurity policy, procedure, and implementation to ensure compliance with regulatory requirements and industry best practices.
  • Develop and implement strategies to improve the WS Information Security Program (WSISP) and ensure continuous monitoring and compliance of HITRUST security controls.
  • Establish and maintain security policies, procedures, and implementation measures that support the WSISP, including configuration management, contingency planning, and incident response.
  • Analyze emerging cybersecurity requirements and identify areas of risk, developing strategy, policy, governance, and implementation guidance recommendations for a holistic risk management approach.
  • Support operations of Caresphere WS post-market surveillance for product issues and complaints, and coordinate with cross-functional risk management, post-market surveillance, and development leadership to provide risk assessment, root cause, resolution, and workaround details.
  • Establish, improve, and monitor the Caresphere WS product suite manufacturing processes, including alignment with HITS Delivery and IT Process Governance teams.
  • Support the IT Process Governance team in internal and external audits (ISO, FDA, MDSAP, etc.) as a subject matter expert for Caresphere WS product suite design and development, post-market surveillance, and manufacturing.
  • Perform manager-type responsibilities for direct reports, including performance management, time reporting, expense management, etc.
Requirements
  • Bachelor's degree required.
  • 5 years of previous experience in Process Management, QA, and/or Security Compliance, HITRUST Technology Specialist/Auditor required.
  • HITRUST CCSFP (Certified Common Security Framework Practitioner) Certification desired.
  • Hands-on experience with audit preparation and running audit sessions for FDA, ISO, and Security audits.
  • Proven ability to work under stress in emergencies with flexibility to handle multiple high-pressure situations simultaneously.
  • Proven leadership abilities, including effective knowledge sharing, conflict resolution, facilitation of open discussions, fairness, and displaying appropriate levels of assertiveness.
  • Ability to communicate highly complex technical information clearly and articulately for all levels and audiences.
  • High critical thinking skills to evaluate alternatives and present solutions that are consistent with business objectives and strategy.
  • Must demonstrate initiative and effective independent decision-making skills.
  • Proficiency in Office Suite (Word, Excel, PowerPoint, Outlook) and Atlassian Suite (Jira, Confluence, Zephyr).
  • Familiarity with Tenable Vulnerability Management, SentinelOne or other End Point Protection software.

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