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.

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