Job Description
Regulatory Affairs (RA) - Quality Assurance (QA) Specialist - Duties are maintain ISO 13485, MDSAP and FDA QSR regulatory & quality compliance standards for medical device manufacturing including draft, implement & maintain QMS in accordance with FDA QSR regulations; assist with prepare 510(k), EU-MDR, CE marking, technical files & post market surveillance reports for medical devices; and conduct internal audits to ensure quality standards & requirements. Requirements are Bach's degree in Healthcare Regulatory Compliance, Healthcare Decisions Analysis, Biomedical Engineering or related field and 3 yrs exp in stated job duties. Salary is $80,000 to $90,000. Position is in Los Angeles, CA with SprintRay, Inc. Send resume to: Teri Rosenthal at teri@sprintray.com