VP, Quality Assurance & Regulatory Affairs - Strategic Leader

Nihon Kohden Orange Med; Santa Ana (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

Nihon Kohden Orange Med is seeking a Vice President of Quality Assurance & Regulatory Affairs to lead the QA, QC, and Regulatory Affairs functions. This executive role requires strategic direction, hands-on involvement in investigations, audits, and regulatory decisions, and close coordination with FDA and international authorities.

The VP will guide product quality across lifecycles, develop risk-management processes, and drive compliance in a global medical device environment, reporting to the

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, Engineering, Life Sciences, or related technical discipline.
• At least 8+ years in quality assurance and 5+ years in regulatory affairs within medical devices.
• Experience leading QA/RA functions and managing teams.
• Strong knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and EU requirements.
• Excellent executive communication, negotiation, and stakeholder management.

Responsibilities

• Provide strategic leadership for QA/RA, quality control, and regulatory affairs.
• Set vision and priorities for QA/RA aligned with business goals.
• Lead a 25-person QA/RA organization and manage budgets, staffing, and metrics.
• Serve as senior advisor on quality, regulatory risk, and product changes.
• Oversee internal audits, CAPA, investigations, and regulatory inspections.

Skills

Executive leadership

Quality Assurance

Regulatory affairs

FDA regulatory

ISO 13485

Quality systems

Audits

Team management

Education

Bachelor’s degree in regulatory/quality/engineering/life sciences

Job description

Nihon Kohden Orange Med is seeking a Vice President of Quality Assurance & Regulatory Affairs to lead the QA, QC, and Regulatory Affairs functions. This executive role requires strategic direction, hands-on involvement in investigations, audits, and regulatory decisions, and close coordination with FDA and international authorities.

The VP will guide product quality across lifecycles, develop risk-management processes, and drive compliance in a global medical device environment, reporting to the