About this role
Sr. RA Specialist at Noah Medical. Location: San Jose, California, United States. Role: supporting strategy, preparing submissions, ensuring compliance Requirements: Bachelor's in engineering/life sciences/regulatory field, 5+ years medical device regulatory affairs experience, experience with FDA 510(k) and international registrations, strong knowledge of FDA, EU MDR, ISO 13485, ISO 14971, MDSAP; RAC preferred; Microsoft Office and eQMS proficiency. Category: Quality Assurance Seniority: Senior Level Tools: Microsoft Office, electronic Quality Management Systems (eQMS) Certifications: rac Commitment: Full Time Workplace: Hybrid Languages: English