General Job Duties Ensures compliance with our client's Quality System and Regulatory Affairs program, reporting to the Director of Quality Operations and serving as their back-up. Maintains and ensures compliance with a comprehensive Quality Management System, including ISO 9001, MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA (21 CFR 820)), FDB, CA-RHB, NRC, BIS, DOT 49 CFR / IAEA, DAkkS / ISO 17025, and Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745) CE Mark. Manages regulatory affairs, including product registrations, licensing (CA-RHB, SS&DRs, CMDR, RMLs), export control, and submissions for international markets. Leads and performs audits (internal, supplier, customer), issues and closes CAPAs, and maintains audit records. Conducts and oversees training for cGMP, new employees, internal auditors, and quality/regulatory systems. Supports documentation control and has final approval on controlled procedures, revisions, and engineering changes. Manages the Customer Complaints and Returns program, evaluating complaints and approving reports. Contributes to company-wide training and assists with hiring, performance appraisals, and employee management. Travel is required to Burbank and Valencia facilities, and for supplier audits and training. Requirements Education: Bachelor’s degree or equivalent in a scientific field. Experience: 5+ years in medical device or pharmaceutical regulatory affairs, including 5+ years of management experience and 5+ years preparing regulatory submissions (FDA, EU MDR, international). Key Skills & Experience: Certified Lead Auditor. Proficiency in MDSAP, MDD, EU MDR/IVD, FDA, QSR/QMSR, ISO standards. Strong documentation, customer service, and communication skills (written and verbal). Ability to lead audits, problem-solve, prioritize, and work independently or in a team. Experience with design control, manufacturing, process development, QA/QC. Proficient in Microsoft Office Suite, ERP systems (e.g., Microsoft Dynamics), and flowcharting programs. Able to lift up to 50 lbs. #J-18808-Ljbffr
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