QA & Regulatory Affairs Manager

Top Job

Located in Santa Clarita, CA

Salary: 110K - 150K

EXCITING OPPORTUNITY FOR GREAT TALENT!  QA & REGULATORY AFFAIRS MANAGER NEEDED FOR AN AMAZING OPPORTUNITY!  CALL MARIA ASAP 661-775-2570.

 

General Job Duties:

• Operates under the guidance of the Director of Quality Operations as necessary, to assure compliance with the company GMP Quality Management System program.
  
  
• Oversees on 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 (Radiological Health Branch-product registrations, compliance, & licensing), Nuclear Regulatory Commission (NRC), Bureau of Industry & Security (BIS), DOT 49 CFR / IAEA, DAkkS / ISO 17025 , and Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745) CE Mark compliant Quality Management System.
• Manages and conducts cGMP and employee trainings.
• Oversees the Regulatory Compliance Program, Corrective Action & Prevention Action (CAPAs) Program and the Internal Audit Program.
• Conducts internal and supplier audits, writes audit reports, issues CAPAs and trains internal auditors to conduct these activities.
• Conducts regulatory reviews and submits product registrations for NRC/CA-RHB SS&DRs, CMDR licenses, RMLs, FDA, MDD/MDR, import / export control, and others as applicable.
• Conducts customer license reviews and contacts regulatory agencies and customers as required.
• Applies for export licenses from BIS and NRC as required.
• Supports Special Form Radioactive Materials compliance.

Requirements:
1.  Minimum education (or substitute experience) required: Bachelor’s degree or equivalent       in a scientific related field.
2.  Minimum experience required: 5 years of relevant experience in medical devices or   

     pharmaceuticals, preferably within Regulatory Affairs or a related field; 5 years of   

     experience managing others. 5 years’ experience in preparing submissions, including but

     not limited to product registrations and customer licensing for FDA, EU MDR, and other

     international markets.
Experience in the following areas:

• Certified Lead Auditor.

Requirements:
1.
Minimum education (or substitute experience) required: Bachelor’s degree or equivalent in a scientific related field.
2.
Minimum experience required: 5 years of relevant experience in medical devices or pharmaceuticals, preferably within Regulatory Affairs or a related field; 5 years of experience managing others. 5 years’ experience in preparing submissions, including but not limited to product registrations and customer licensing for FDA, EU MDR, and other international markets.

Experience in the following areas:

• Certified Lead Auditor.
• Customer service experience and handling customer complaints
• Excellent problem solving, prioritizing, and time management skills
• Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
• Proficient in Microsoft Dynamics or equivalent ERP system, Microsoft Office Suite applications (Word, Excel, PowerPoint), Teams, SharePoint, and SmartDraw or equivalent flowcharting program 
• Able to lift up to 50 lbs.

Qualified applicants with arrest or conviction records will be considered for employment following the law. Including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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