QA/RA Manager

BioTalent; Santa Clarita (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

A medical devices company located in Santa Clarita seeks a Quality Assurance & Regulatory Manager to support compliance with regulatory requirements. This full-time role involves managing quality systems, leading audits, and overseeing training programs. The ideal candidate has over 5 years of experience in regulatory affairs, especially in medical devices. This position demands strong leadership, communication skills, and expertise in FDA submissions and compliance standards. A Bachelor's degree in a scientific field is essential.

Qualifications

• Proven experience preparing FDA, EU MDR, and international regulatory submissions.
• Strong understanding of MDSAP, EU MDR/IVD, FDA QSR/QMSR, ISO standards.
• Experience with QA/QC, design control, manufacturing, and process development.

Responsibilities

• Support the Director of Quality Operations.
• Maintain compliance with relevant regulations.
• Oversee quality systems and training programs.
• Conduct audits and prepare reports.
• Manage quality and regulatory training.

Skills

Leadership in a management role

Regulatory Affairs expertise

FDA submission experience

Internal and supplier audits

Excellent communication skills

Problem-solving and time management

Document management abilities

ERP proficiency (Microsoft Dynamics, etc.)

Education

Bachelor’s degree in a scientific field or equivalent experience

Tools

Microsoft Office

Microsoft Teams

Microsoft SharePoint

Job description

This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$110,000.00/yr - $150,000.00/yr

Direct message the job poster from BioTalent

Lead Engineering, Regulatory, Quality and Clinical Affairs Recruiter, Medical Device & Diagnostics at BioTalent and Investigo, part of The IN Group

Position: Quality Assurance & Regulatory Manager

Department: Quality Operations

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance and Engineering

Industries

• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing

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