Hiring: Sr. RA Specialist Company: Noah Medical Location: San Jose, CA Job Posted Time: 2026-09-16 15:18:47 Employment Type: Full-time / Remote Target Skills & Keywords : Agile, Regulatory Compliance About the job Experience: •5+ years of Regulatory Affairs experience within the medical device industry. Qualifications: •Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related technical discipline. Advanced degree preferred. •Solid functional working knowledge of medical device development processes and design controls. •Strong knowledge of: FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements •Regulatory Affairs Certification (RAC) preferred. •Strong project management and organizational skills. •Excellent written and verbal communication skills. •Strong analytical and problem-solving abilities. •Demonstrated capacity to work independently with minimal supervision. Compensation: •$109,000 - $136,000 / year •Flexible work environment (work from home / hybrid options) •Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!