Cybersecurity and Compliance Lead

Role: Serve as a technical subject matter expert in product cybersecurity and regulatory compliance within a biopharma context, supporting regulated products such as medical devices or diagnostics. Responsibilities: lead threat modeling, security architecture reviews, and Secure Product Development Framework activities; provide cybersecurity guidance for regulatory submissions (FDA, IVDR, PMDA); support cybersecurity risk assessments, vulnerability management, and supply chain security. Collaborate with Regulatory, Quality, Engineering, and IT teams to ensure cybersecurity practices are integrated into product lifecycle and regulatory documentation. Requirements: 7+ years in cybersecurity, application security, or product security, with experience supporting software development in regulated environments; strong stakeholder management and cross-functional leadership skills. Preferred: experience with medical device or biotech products, security frameworks (ISO 27001, NIST), and certifications (CISSP, CISM, etc.). High-Value: focus on regulated biopharma products, cybersecurity risk management, threat modeling, secure architecture, and compliance documentation; support for regulatory filings and audits. Work Setup: full-time in the USA, remote or hybrid, with no travel specified.