Senior Regulatory Affairs Program Lead (Software/OTTAVA)

Accountabilities: Develop and execute regulatory strategies for new product development (NPD) and lifecycle management (LCM) projects. Act as the strategic regulatory lead throughout product development, regulatory submission, approval, and lifecycle management activities. Serve as a regulatory subject matter expert for software-enabled electromechanical medical devices, including robotic systems. Review product specifications, device testing plans, risk management documentation, labeling, and other technical materials, providing regulatory guidance and ensuring submission readiness. Prepare, author, and submit regulatory documentation to support timely US market access, including FDA Q-Submissions, Investigational Device Exemptions (IDEs), De Novo requests, and 510(k) submissions. Lead preparation for FDA meetings and support communications with health authorities. Execute sustaining regulatory activities, including change assessments, Letters to File, registrations, and renewals. Support the preparation of technical documentation for submissions to international health authorities. Apply expert knowledge of relevant regulatory guidance, legislation, and industry standards to product development and regulatory strategies. Support regulatory audits and help ensure ongoing compliance. Requirements: Bachelor's degree required; an advanced degree is strongly preferred. At least 6 years of regulatory affairs experience in the medical device industry, including experience with software-enabled systems. Proven track record of obtaining regulatory approvals, such as 510(k) clearances, IDE approvals, and De Novo authorizations. Experience supporting US market access and regulatory submissions. Strong understanding of regulatory requirements for medical device development, including the ability to assess new and changing regulations and determine their impact on projects. Demonstrated ability to lead multiple complex projects and manage detailed regulatory activities. Excellent cross-functional communication and collaboration skills, with the ability to influence stakeholders across regulatory and other business functions. Strong independent judgment and strategic thinking, including the ability to interpret regulatory guidance, requirements, and industry trends and translate them into practical business strategies. Advanced analytical and problem-solving skills, flexibility, and comfort working through ambiguity. Willingness to travel up to 10%. Preferred Qualifications: Experience preparing for and participating in health authority meetings. Background in vision systems, robotics, or connected medical platforms. Familiarity with the IEC 60601 series and ISO 10993-1 standards. Strong knowledge of FDA regulatory requirements relating to medical device software and cybersecurity. Benefits: Annual base salary range of $112,000–$180,550. For the San Francisco Bay Area, the annual base salary range is $129,000–$208,150. Eligibility to participate in retirement and savings plans, including a pension plan and 401(k), subject to applicable plan terms. 120 hours of vacation per calendar year. 40 hours of sick time annually, with higher allocations in certain states. 13 paid holidays, including floating holidays. Up to 40 hours of work, personal, and family time per year. Up to 480 hours of parental leave within one year of a child's birth, adoption, or foster care placement. Bereavement leave, including up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year. Up to 80 hours of caregiver leave within a rolling 52-week period. 32 hours of volunteer leave per calendar year. 80 hours of military spouse time off per calendar year. Fully remote work arrangement, with remote eligibility subject to approval; preference may be given to candidates within commuting distance of Santa Clara, California.