Manager, Technical Product & Security Compliance

Sysmex - Lincolnshire, IL

Full-time - Manager

Lincolnshire, IL

About the position

The Manager, Technical Product & Security Compliance at Sysmex is a pivotal role responsible for overseeing the development, maintenance, operations, and compliance of the cybersecurity program specifically for medical device software products manufactured at Sysmex America, Inc. This position plays a crucial role in ensuring that the cybersecurity measures align with regulatory requirements, customer standards, and industry best practices. The manager will also be a key stakeholder in the cybersecurity roadmap for Corporate Systems & Innovation applications, ensuring compliance and standardization across the board. In this role, the manager will lead efforts to maintain the independent third-party HITRUST certification. This involves reviewing and approving all security requirements and collaborating with internal stakeholders and third-party partners to successfully pass audits necessary for obtaining and maintaining certification. The manager will provide consultation services to leadership regarding cybersecurity policies and procedures, ensuring that all changes are managed effectively and that cross-functional teams are aligned with any new or modified processes. The position requires continuous monitoring and compliance of HITRUST security controls, ensuring they are implemented correctly and producing the desired outcomes. The manager will also be responsible for establishing and reviewing security policies and procedures that support the Information Security Program, including risk assessments and incident response plans. Additionally, the role involves analyzing emerging cybersecurity requirements, identifying risks, and developing strategies and policies to address these challenges. The manager will support operations related to post-market surveillance for product issues and complaints, coordinating with various teams to provide risk assessments and resolutions. Furthermore, the role includes responsibilities for internal and external audits, acting as a subject matter expert for the product suite design and development, and managing direct reports effectively.

Responsibilities

• Provide consultation services to leadership on cybersecurity policy, procedure, and implementation to ensure compliance with regulatory requirements and industry best practices.
• Manage change and align cross-functional teams impacted by added or modified processes.
• Direct and strategize the WS Information Security Program (WSISP) improvement, implementation, and operations.
• Continuously monitor and ensure compliance of HITRUST security controls for assigned systems.
• Establish and review security policies, procedures, and implementation measures that support the WSISP.
• Analyze the impact of emerging cybersecurity requirements and develop strategies and policies accordingly.
• Support operations of Caresphere WS post-market surveillance for product issues and complaints.
• Establish and monitor manufacturing processes for the Caresphere WS product suite.
• Support the IT Process Governance team in internal and external audits as a subject matter expert.
• Perform managerial responsibilities for direct reports, including performance management and expense management.

Requirements

• Bachelor's degree required.
• 5 years of previous experience in Process Management, QA, and/or Security Compliance.
• HITRUST Technology Specialist/Auditor experience required.
• HITRUST CCSFP 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 and handle multiple high-pressure situations simultaneously.
• Proven leadership abilities including effective knowledge sharing and conflict resolution.
• Ability to communicate complex technical information clearly for all levels and audiences.
• High critical thinking skills to evaluate alternatives and present solutions consistent with business objectives.
• Demonstrated initiative and effective independent decision-making skills.

Nice-to-haves

• Experience with Tenable Vulnerability Management software.
• Experience with SentinelOne or other End Point Protection software.