Candidate ID: F24010
Regulatory Affairs & Quality Assurance Manager
8 years of experience
Current Location: Irvine, CA
Candidate Summary
This candidate is a highly experienced regulatory affairs and quality assurance specialist with a background in both medical devices and pharmaceuticals. This candidate possesses skills in team management, regulatory strategies, internal/external audit, Class 1 and Class 2 device submissions and 510k submissions.
Qualifications: Master of Biotechnology Studies (MBt), Applied Biotechnology Studies and Regulatory Affairs
Work Model: Hybrid, In-office
Candidate Availability: 4 weeks
Salary Expectations: $150,000 base
Key Skills: Class 1 submissions, Class 2 submissions, US FDA, Health Canada, International, MDR Submissions, LATAM, China, North America, Internal Audit, Regulatory strategies, Quality Regulations
