Regulatory Affairs Manager
: Job Details :

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.

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