QA/RA Manager

Position: Quality Assurance & Regulatory Manager

Department: Quality Operations

Location: Valencia & Burbank

Type: Onsite

Job Summary

The Quality Assurance & Regulatory Manager supports the Director of Quality Operations and ensures the company meets all GMP, Quality, and Regulatory requirements. This role oversees key quality systems, regulatory submissions, audits, document control, and training programs across both sites.

Key Responsibilities

• Support the Director of Quality Operations and act as backup when needed.
• Serve as the company’s Calibration Laboratory Management Representative.
• Maintain compliance with ISO 9001, MDSAP/ISO 13485, FDA 21 CFR 820, EU MDR, CA-RHB, NRC, BIS, DOT/IAEA, ISO 17025, and other relevant regulations.
• Manage cGMP, Quality, and Regulatory training programs.
• Oversee all quality systems, including Regulatory Compliance, CAPA, and Internal Audit programs.
• Conduct and lead internal and supplier audits; prepare reports, issue CAPAs, and train auditors.
• Prepare and submit regulatory assessments, product registrations, and licenses for FDA, NRC/CA-RHB, CMDR, EU MDR, and other markets.
• Communicate with regulatory agencies and customers; review customer licenses.
• Submit export license applications (BIS, NRC) when required.
• Support compliance for Special Form Radioactive Materials.
• Approve test reports, certifications, procedures, drawings, and change orders.
• Manage the Document Management Program and maintain controlled procedures.
• Oversee customer complaints and returns and provide final approval of reports.
• Lead or support audits and follow-up activities.
• Manage hiring, training, goal-setting, performance evaluations, and daily activities for department staff.
• Travel between Valencia and Burbank and to suppliers as needed.
• Perform other duties as assigned.

Education:

• Bachelor’s degree in a scientific field or equivalent experience.

Experience & Skills:

• 5 years in medical devices or pharmaceuticals, ideally in Regulatory Affairs.
• 5 years in a management role.
• Proven experience preparing FDA, EU MDR, and international regulatory submissions.
• Certified Lead Auditor; skilled in internal, supplier, and customer audits.
• Strong understanding of MDSAP, EU MDR/IVD, FDA QSR/QMSR, ISO standards, and related regulations.
• Excellent communication skills and experience working with regulatory bodies.
• Strong documentation, problem-solving, time-management, and organizational abilities.
• Experience with QA/QC, design control, manufacturing, and process development.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency with Microsoft Dynamics or other ERPs, Microsoft Office, Teams, SharePoint, and flowchart tools.
• Ability to lift up to 50 lbs.