Cybersecurity and Compliance Lead

Overview The Product Cybersecurity and Compliance Lead serves as the technical subject matter expert for product cybersecurity and regulatory cybersecurity compliance initiatives. The role partners with the Director of Information Security, Product Development, Engineering, Regulatory Affairs, and Quality teams to integrate cybersecurity into the product lifecycle and support regulatory submissions requiring cybersecurity evidence and documentation. This role provides technical leadership for Secure Product Development Framework (SPDF) activities, threat modeling, architecture reviews, cybersecurity risk assessments, and compliance initiatives. The position also coordinates cybersecurity workstreams, supports regulatory and product teams, and helps establish sustainable cybersecurity practices across regulated product programs. Responsibilities Product Cybersecurity Leadership Serve as a technical SME for product cybersecurity activities across regulated products.  Provide cybersecurity guidance for FDA, PMDA, IVDR, and related regulatory requirements.  Lead threat modeling, security architecture reviews, and SPDF activities.  Promote security-by-design practices throughout the product lifecycle.  Provide cybersecurity input for new products, enhancements, and regulatory submissions.  Partner with the Director of Information Security to mature product cybersecurity capabilities. Cybersecurity Compliance Partner with Regulatory Affairs, Quality, Product, and Engineering teams on cybersecurity compliance initiatives.  Support development of cybersecurity evidence and documentation for regulatory submissions.  Translate cybersecurity regulations and standards into technical requirements.  Participate in audits, assessments, and remediation activities.  Maintain cybersecurity compliance documentation and supporting artifacts. Security Assessments & Risk Management Conduct product cybersecurity risk assessments and threat analyses.  Review software supply chain security controls and contribute to SBOM processes.  Coordinate vulnerability assessments, penetration testing, and remediation efforts.  Support cybersecurity risk management documentation and evidence generation.  Review product architectures and designs for cybersecurity risks.   Cross-Functional Coordination & Execution Coordinate cybersecurity workstreams across Product, Engineering, QA, Regulatory Affairs, IT, and Information Security.  Track cybersecurity deliverables, dependencies, and regulatory milestones.  Facilitate technical reviews, threat modeling sessions, and cybersecurity working meetings.  Identify risks, blockers, and resource constraints affecting deliverables.  Support cybersecurity roadmap planning and execution. Security Architecture & Consultation Advise teams on secure design principles and secure development practices.  Review application, cloud, infrastructure, and system designs.  Recommend cybersecurity controls aligned with regulatory and business requirements.  Support implementation of secure development and data protection practices.  Help establish repeatable cybersecurity practices across product development teams. Required Qualifications 1. 7+ years of cybersecurity, application security, or product security experience. 2. Experience supporting software development or product engineering organizations. 3. Experience with threat modeling, architecture reviews, and secure SDLC practices. 4. Experience conducting product cybersecurity risk assessments. 5. Experience supporting regulated products or regulated software development environments. 6. Strong communication and stakeholder management skills. 7. Ability to lead cross-functional initiatives without direct authority. Preferred Qualifications 1. Experience with medical device, diagnostics, biotechnology, healthcare, or other regulated products. 2. Experience supporting cybersecurity components of regulatory submissions. 3. Experience with SBOM management and software supply chain security. 4. Experience with HITRUST, ISO 27001, NIST CSF, or similar security frameworks. 5. CISSP, CCSP, CSSLP, CISM, AWS Security Specialty, GIAC, or equivalent cybersecurity certifications.  Required  U.S. citizen or national Green Card holder  Living full time in the USA  We take geographic location into account when determining base salary to ensure equitable and competitive compensation.  #LI-KO1 Physical Requirements Use of equipment and tools necessary to perform essential job functions. EEO We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as any mental health or physical disability needs.