Back to jobs

Regulatory Affairs Manager

Job description

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
  1. Education: Bachelor’s degree or equivalent in a scientific field.
  2. 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).
  3. 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.