Senior Regulatory Affairs Lead - Medical Devices (Hybrid)

System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, CA, to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. This 6‑month contract role requires deep regulatory expertise and strong cross‑functional leadership. The ideal candidate will drive regulatory plans, author pivotal documents such as 510(k) submissions, and coordinate with international teams to support global approvals. Hybrid work with onsite days is offered. #J-18808-Ljbffr System One