Technical Lead, Cybersecurity - RIS Quality & Regulatory

Roche • Washington, DC

236d • $127,000 - $236,000 • Hybrid

About The Position

At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. As the Cybersecurity Lead, your main objectives are to support the Global Quality and Regulatory Affairs (Q&R) organization to inform the best design strategies for managing threats to the portfolio and products, support policy work related to cybersecurity in coordination with our Regulatory Policy and Intelligence (RPI) group, and lead internally and externally on matters related to diagnostic and medical device cybersecurity regulatory requirements with an impact to the Roche product portfolio. As a Cybersecurity expert in the diagnostic and medical device space, you will be responsible for establishing and maintaining a robust cybersecurity posture for our products. You will leverage your deep understanding of cybersecurity principles, medical device regulations, and industry best practices to identify, assess, and mitigate security risks throughout the product lifecycle. This role requires strong technical and regulatory expertise, excellent communication skills, and the ability to collaborate effectively with cross-functional teams.

Requirements

• Bachelor or Advanced degree in Computer Science, Cybersecurity, Law, Biomedical Engineering, or a related field.
• Minimum of 8+ years of experience in cybersecurity, with a significant focus on medical devices or other regulated industries.
• Knowledge in Diagnostics, Pharmaceutical, and/or Medical Device industry; Regulatory Compliance, Federal cGMP's and QSR's, ISO13485 and 27001.
• Knowledge of FDA guidelines on medical device cybersecurity, ISO 14971, IEC 62304, NIST (e.g., NIST 800-53), and HIPAA.
• Knowledge of specific programming languages and technologies used in medical device development.
• Experience with incident response processes and methodologies.
• Experience with cloud security and IoT security in the context of medical devices.
• Familiarity with the Software Bill of Materials (SBOM) and its importance in medical device cybersecurity.
• Experience with penetration testing methodologies and tools.

Nice To Haves

• Leadership & Senior Management Skills.
• Experience working in a matrixed organization.
• Ability to build strong relationships and effective stakeholder management.
• Experience leading, motivating, coaching, and developing teams.

Responsibilities

• Assess and develop individual project and portfolio strategies, in conjunction with project leads, as well as identify and apply feasible approaches to ensuring cybersecurity.
• Collaborate with internal stakeholders from multiple global functions and affiliates, and external stakeholders, in particular the US FDA, on cybersecurity matters across all of our customer areas, both product-specific and above product.
• Support and lead projects in the Roche Diagnostic Policy and Strategy agenda related to cybersecurity topics.
• Drive prioritized strategies and deliverables related to cybersecurity that have the greatest impact for our customers.
• Develop and implement robust cybersecurity strategies for our products and portfolio to support successful submissions and assess the impact of new and changing regulations to the product portfolio.
• Empower and enable project teams and act as Senior Advisor and Coach.
• Ensure the Implementation of Risk Assessment and Management Across the Portfolio.
• Conduct comprehensive portfolio and/or project level cybersecurity risk assessments of diagnostics and medical devices, associated software, and networks.
• Ensure Compliance with Industry Standards.
• Partner to Ensure Security Design and Implementation Across the Product Portfolio.
• Define security requirements and specifications for diagnostics, medical devices and software.
• Monitor Threat Intelligence and Vulnerability Management.
• Engage in Incident Response and Security Awareness and Training.

Benefits

• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree